Waktu Kerja Tetap:
7am - 11am (4 Jam)
Hari Kerja Tetap:
Selasa, Rabu, Khamis, Jumaat & Ahad (5 Hari)

Benefit:
- Ada AL & MC
- Ada Payslip
- Contract selama 6 bulan - 1 tahun

Bayaran: Secara Bulanan

• RM 50_HALF DAY = 4 hours
• +Travelling Allowances
• Potongan EPF, SOCSO & EIS

Skop Kerja:
- Memuat & Memunggah produk
- Pengimbasan Produk
- Menyusun dan mengasingkan produk
- Bekerja rapat dengan ahli pasukan
- Latihan akan diberikan
- Perlu mempunyai Kereta sendiri
- Datang kerja menggunakan kereta sahaja
- Perlu divaksinasi sepenuhnya
- Min peringkat pendidikan SPM
- Malaysia SAHAJA
- Gaji secara Online Transfer

Sedang bekerja di dalam KLIA Cargo & mempunyai MAB pass akan diutamakan.

Resume box: lifework.sun@gmail.com

Perks & Benefits

• Allowance (travel stipends, transportation, etc.)

固定工作時間：
上午 7 點至上午 11 點（4 小時）
固定工作日：
週二、週三、週四、週五和週日（5 天）

好處：
- 有AL和MC
- 有薪資單
- 合約為期 6 個月 - 1 年

付款方式：每月

• RM 50_半天 = 4 小時
• +旅遊津貼
• EPF、SOCSO 和 EIS 扣除

工作範圍：
- 裝卸產品
- 產品掃描
- 分類與分類產品
- 與團隊成員密切合作
- 將提供培訓
- 必須擁有自己的汽車
- 只能開車上班
- 必須完全接種疫苗
- 平均SPM教育水平
- 僅限馬來西亞
- 線上薪資轉賬

目前在 KLIA Cargo 工作並擁有 MAB 通行證者優先。

履歷箱：lifework.sun@gmail.com

津貼和福利

• 津貼（旅費、交通費等）

Job Description

The primary focus of the exa-cel External Manufacturing Senior Manager role is to support External Manufacturing (ExM) with managing various activities to support execution of CMC, Clinical and Commercial manufacturing but also drive and support execution of strategies for life cycle management. This role will also provide leadership for project management activities and business processes such as SOW/PO and management of elements of batch disposition.

We are looking for a candidate with breadth of professional experience to organize and drive work with both internal and external partners. The right candidate should have the ability to understand the challenges and proactively collaborate with other stakeholders for resolution of issues and delivery of tasks on time. The successful candidate should have industry experience, knowledge of cGMPs, a quality and compliance mindset, and proven project management abilities.  The successful candidate will work within a matrix team environment and will participate in and/or lead various forums while contributing to the broader External Manufacturing group activities and responsibilities. 

This is a hybrid position based in Paddington, London.

Key Responsibilities

• Manage on-time disposition of batches. This activity includes managing successful closure key components of exa-cel drug product disposition such as batch records and deviations, environmental monitoring, internal and external analytical testing. Close liaison with internal and CMO staff will be required to monitor daily, communicate progress and/or escalate to Virtual Plant Team (VPT) and Supply Chain and drive resolution for key issues.

• Provide project management support to the VPT for ‘run the business’ and life cycle management activities. These tasks may include collaboration with internal and external stakeholders through joint project teams, support/leadership for initiatives / projects, disposition, and other business priorities. This role will also support coordination, maintenance and facilitation of QMS data to support timely disposition of products.  Provide support to VPT and the Global Manufacturing Operations Team (GMOT) with meeting logistics (including coordination of agendas, issuing meeting minutes, following up on open actions, recording of decisions), tool/system enhancement, collation of data and maintenance of dashboards for KPI performance. The role will also support initiation and closure of quality records such as deviations, CAPAs and/or Change Controls.

• Function as the primary point of contact for the ExM PO/SOW business process, establishing and maintaining business processes while collaborating with cross functional colleagues in Finance, Legal, and other technical teams to track against budget. This role will also collaborate with the Contract Manufacturing and Development Organizations (CDMO) and VPT on the intake of the Scope of Works (SOWs) and coordination of the internal review and approval of these documents.  The responsibilities include initiating Purchase Orders (POs) and management of POs and invoices.

• ExM Business processes – take the lead identifying internal/external systems and gaps, then align, and share best practices.  Ensure ExM US and International business systems stay aligned.  Look externally to understand best practice and bring in house.  Work closely with internal Project Management Office to stay aligned with best internal practices.

• Provide oversight to the training curriculum for ExM Cell and Gene Therapies and Small Molecule organization.  This activity will include auditing of the training requirements for various levels to ensure accuracy and liaison with the training function to make proper adjustments. Partner with the ExM team to monitor training adherence. Closely partner with the Project Management Organization for sharing of experiences and tools.

Minimum Requirements:

• Bachelor’s degree in life sciences or related field. Industry knowledge and experience with manufacturing and quality environments.
• Strong quality mindset in a commercial GMP biopharmaceutical operations
• Solid project management skills and experience managing complex projects.
• Strong verbal and written communication skills: ability to express oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience.
• Strong leadership and an innate ability to collaborate and build relationships is critical.
• Ability to work calmly and make sound decisions in a fast-moving environment of uncertainty and change.
• Flexibility to work shift hours required to cover critical process steps.
• Represent Vertex as a leader when issues arise.

Preferred Requirements:

• BS /BA in in Life Sciences or related discipline (Immunology, Microbiology, Cell Biology, Engineering, etc.) with broad relevant experience in biotech or pharmaceutical industries, ideally in a senior manufacturing leadership role working with or in cGMP facilities within the biotechnology industry.
• Strong technical background in ATMPs, including cell and genetic therapy related manufacturing operations, ideally autologous cell therapy experience.
• Experience operating effectively in a matrix team environment.

#LI-Hybrid

#LI-SM1

Company Information

Description -

What a Manufacturing Technician does at HP:

• Applies basic knowledge of the job skills and company policies and procedures to complete a variety of assignments/tasks.
• Good understanding of the general/technical aspects of the job.
• Works on assignments that are routine to moderately complex in nature and require basic problem resolution and independent judgment.
• Allocates own time efficiently.
• Receives general instructions on all work.

Individuals who do well in this role at HP, usually possess:

• Typically, an Associate's degree or equivalent experience and/or 1-2 years related experience.
• May include highly experienced individuals performing entry-level equivalent work who are non-degreed or degreed in an unrelated field.
• Basic knowledge in the field of electromechanical technology.

Sustainable impact is HP’s commitment to create positive, lasting change for the planet, its people, and our communities. This serves as a guiding principle for delivering on our corporate vision – to create technology that makes life better for everyone, everywhere.

Job -

Schedule -

Shift -

Travel -

Relocation -

Equal Opportunity Employer (EEO) - 

HP, Inc. provides equal employment opportunity to all employees and prospective employees, without regard to race, color, religion, sex, national origin, ancestry, citizenship, sexual orientation, age, disability, or status as a protected veteran, marital status, familial status, physical or mental disability, medical condition, pregnancy, genetic predisposition or carrier status, uniformed service status, political affiliation or any other characteristic protected by applicable national, federal, state, and local law(s).

Please be assured that you will not be subject to any adverse treatment if you choose to disclose the information requested. This information is provided voluntarily. The information obtained will be kept in strict confidence.

If you’d like more information about HP’s EEO Policy or your EEO rights as an applicant under the law, please click here: Equal Employment Opportunity is the Law Equal Employment Opportunity is the Law – Supplement

Description -

Job -

Schedule -

Shift -

Travel -

Relocation -

Equal Opportunity Employer (EEO) - 

HP, Inc. provides equal employment opportunity to all employees and prospective employees, without regard to race, color, religion, sex, national origin, ancestry, citizenship, sexual orientation, age, disability, or status as a protected veteran, marital status, familial status, physical or mental disability, medical condition, pregnancy, genetic predisposition or carrier status, uniformed service status, political affiliation or any other characteristic protected by applicable national, federal, state, and local law(s).

Please be assured that you will not be subject to any adverse treatment if you choose to disclose the information requested. This information is provided voluntarily. The information obtained will be kept in strict confidence.

If you’d like more information about HP’s EEO Policy or your EEO rights as an applicant under the law, please click here: Equal Employment Opportunity is the Law Equal Employment Opportunity is the Law – Supplement

Description -

What a Manufacturing Technician does at HP:

• Applies basic knowledge of the job skills and company policies and procedures to complete a variety of assignments/tasks.
• Good understanding of the general/technical aspects of the job.
• Works on assignments that are routine to moderately complex in nature and require basic problem resolution and independent judgment.
• Allocates own time efficiently.
• Receives general instructions on all work.

Individuals who do well in this role at HP, usually possess:

• Typically, an Associate's degree or equivalent experience and/or 1-2 years related experience.
• May include highly experienced individuals performing entry-level equivalent work who are non-degreed or degreed in an unrelated field.
• Basic knowledge in the field of electromechanical technology.

Sustainable impact is HP’s commitment to create positive, lasting change for the planet, its people, and our communities. This serves as a guiding principle for delivering on our corporate vision – to create technology that makes life better for everyone, everywhere.

Job -

Schedule -

Shift -

Travel -

Relocation -

Equal Opportunity Employer (EEO) - 

HP, Inc. provides equal employment opportunity to all employees and prospective employees, without regard to race, color, religion, sex, national origin, ancestry, citizenship, sexual orientation, age, disability, or status as a protected veteran, marital status, familial status, physical or mental disability, medical condition, pregnancy, genetic predisposition or carrier status, uniformed service status, political affiliation or any other characteristic protected by applicable national, federal, state, and local law(s).

Please be assured that you will not be subject to any adverse treatment if you choose to disclose the information requested. This information is provided voluntarily. The information obtained will be kept in strict confidence.

If you’d like more information about HP’s EEO Policy or your EEO rights as an applicant under the law, please click here: Equal Employment Opportunity is the Law Equal Employment Opportunity is the Law – Supplement

Description -

Job -

Schedule -

Shift -

Travel -

Relocation -

Equal Opportunity Employer (EEO) - 

HP, Inc. provides equal employment opportunity to all employees and prospective employees, without regard to race, color, religion, sex, national origin, ancestry, citizenship, sexual orientation, age, disability, or status as a protected veteran, marital status, familial status, physical or mental disability, medical condition, pregnancy, genetic predisposition or carrier status, uniformed service status, political affiliation or any other characteristic protected by applicable national, federal, state, and local law(s).

Please be assured that you will not be subject to any adverse treatment if you choose to disclose the information requested. This information is provided voluntarily. The information obtained will be kept in strict confidence.

If you’d like more information about HP’s EEO Policy or your EEO rights as an applicant under the law, please click here: Equal Employment Opportunity is the Law Equal Employment Opportunity is the Law – Supplement

Job Description

The Manager, Regulatory CMC (Chemistry, Manufacturing, Controls) will influence the execution of multi-product global regulatory CMC strategies for investigational and marketed products. This role contributes to the preparation and submission of regulatory CMC documentation and with interactions with Health Authorities for CMC topics. This role also provides regulatory support and guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into investigational and commercial programs.

Key Duties and Responsibilities:

• Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
• Contributes to the development of global regulatory CMC strategies for investigational and/or commercial products
• Works with regulatory colleagues in development of global regulatory CMC strategies and submissions
• Provides regulatory CMC guidance to cross-functional teams and key stakeholders
• Influences regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
• Participates effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects.

Knowledge and Skills:

• Strong interpersonal skills to exchange complex information with others and to guide others
• Proficiency in regulatory (FDA, EMA, International and ICH) guidelines
• Experience in the preparation, including writing, of CMC submissions
• Strategic thinking and strong problem solving skills
• Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner
• Strong sense of planning and prioritization, and the ability to work with all levels of management
• Capable of strategic thinking with ability to resolve complex and ambiguous situations
• Sound knowledge of cGMP, FDA, EMA, ICH.

Education and Experience:

• Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
• Strong experience in the pharmaceutical industry or related field.

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work:

1. Hybrid and work remotely up to two days per week; or select

2. On-Site and work 5 days per week with ad hoc flexibility.  

Company Information

Job Description

PLEASE NOTE: The primary location for this role is Edinburgh. A second possible location would be London.

The primary focus of the Associate Director/Principal Engineer, External Manufacturing role is to oversee Vertex’s critical cell and gene therapy Contract Development and Manufacturing Organizations (CDMOs) and implement our vision for this business-critical function. We are looking for a candidate with the breadth of professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of cell and gene therapy products from clinical through post-approval lifecycle management. The right candidate should have the ability to understand the challenges and make proactive decisions after anticipating cross-functional and patient impact.  The successful candidate should have a strong operational, quality, compliance and technical background, with proven project management and supplier management abilities.  The candidate will be located either at the cell and gene therapy CDMO’s site and/or be able to travel to those sites routinely as a “Person-in-Plant”. The successful candidate will be a key member of the Vertex/CDMO Virtual Plant Team (VPT) contributing to the broader External Manufacturing group activities. 

Key Responsibilities:

• Function as the first/primary point of contact for all Vertex interests/activities at certain ATMP cell and gene therapy Contract Development and Manufacturing Organizations (CDMOs)
• Provide operational oversight of, and troubleshooting support to, CDMOs to ensure all deliverables meet or exceed Vertex requirements (including but not limited to successful execution of manufacturing operations, on-time shipments, quality compliance and cost management) - be Vertex’s eyes and ears' at the CDMO for flawless execution of commercial operations
• Maintain on-site presence at certain CDMO facilities for extended periods (including some off-hours/days to resolve urgent issues) during clinical batch manufacturing, Health Authority inspections and other critical activities.  It is anticipated that routine Person-in-Plant oversight will decrease over time.
• Liaison with internal and CDMO stakeholders and leadership on business operations including but not limited to contract management, forecast communication, compliance and finance (eg. issuance of POs and reconciliation/validation of invoices).
• Leverage Technical, Quality and Regulatory SMEs to provide guidance to CDMOs and ensure cross-functional alignment on program priorities and deliverables from clinical through commercial manufacturing and supply.  This includes working closely with CDMO and internal stakeholders on preparations for pre-approval inspection and commercialization-readiness.
• Manage and track CDMO performance prior to (preparation), during (direct oversight) and after (campaign summaries/reports) manufacturing.
• Manage and track batch data in appropriately compliant (data-integrity) systems to support filing submissions, patient planning and process optimization.
• Work closely with CDMO and internal Quality and Technical teams to prioritize and track efficient documentation (including but not limited to change controls, investigations, and deviations) to meet Vertex program requirements.
• Act as the key liaison to facilitate periodic CAPA effectiveness reviews at CDMOs.
• Establish a robust tracking and reporting process to ensure compliance with KPI’s, internal/external audit observation deadlines or other regulatory commitments.
• Collaborate with CDMO and internal stakeholders to understand planned changes and manage the end-to-end implementation of agreed changes including but not limited to change controls and impact assessments.
• Facilitate collation of data to track CDMO performance and compliance on metrics/KPIs including but not limited to contractual agreements, batch release, spend/budget, product quality and supply integrity
• Identify and escalate business-critical issues to Commercial Manufacturing and Supply Chain and Quality leadership.
• Lead continuous improvement initiatives to affect timely resolution of supply issues.
• Build and maintain strategic relationships within the CDMO organization as well as key internal stakeholders.
• Live the Vertex values.

Minimum Requirements:

• BSc in Life Sciences or related discipline (Immunology, Microbiology, Cell Biology, Engineering, etc.) with 8 years of relevant experience in biotech or pharma industries, working with or in GMP facilities within biotechnology industry.
• Strong quality and compliance background in a commercial GMP biopharmaceutical operations (manufacturing and quality) environment; sound working knowledge of health authority regulations.
• Strong technical background in aseptic manufacturing operations.
• Solid project management skills and experience managing complex projects.
• Strong verbal and written communication skills: ability to expresses oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience.
• Strong leadership and an innate ability to collaborate and build relationships is critical.
• Ability to work calmly and make sound decisions in a fast-moving environment of uncertainty and change
• Flexibility to work shift hours required to cover critical process steps
• Ability to travel, national and international, up to 30%
• Strong technical background in cell and genetic therapy related manufacturing operations, ideally autologous cell therapy experience. 
• Solid experience in equipment and facility qualification and validation for ATMP CDMO’s 
• Represent Vertex as a leader when issues arise.

#LI-HYBRID #LI-SM1

Company Information

About Our Job

Denver International Airport (DEN) is seeking an CDL Equipment Operator II (EO II) to join our team! With competitive pay, great benefits, and endless opportunities, working for the City and County of Denver means seeing yourself working with purpose — for you, and those who benefit from your passion, skills and expertise. Join our diverse, inclusive and talented workforce of more than 11,000 team members who are at the heart of what makes Denver, Denver. 

About You

What You’ll Bring

• Knowledge of motor vehicle engines, parts, and systems, including their designs, uses, repair, and maintenance

• Understanding of the designs, installation, uses, repair, and maintenance of machines and tools

• A thorough understanding of safety hazards and necessary precautions to establish a secure work environment for yourself and others

• A team-focused work ethic emphasizing punctuality, flexibility, collaboration, and innovation

• Availability to commit to a variable work schedule, especially during emergencies and inclement weather

• Attention to detail in the field as well as basic computer skills, are also desired qualities

We realize your time is valuable, so please do not apply unless you have the following minimum qualifications:

• Education requirement: Graduation from high school or the possession of a GED, HiSET or TASC Certificate

• Experience Requirement: 3 years of general labor experience, with at least 2 years involving the operation of light to medium-sized equipment (Patch Truck, Pelican Sweepers, Crosswinds, Telescopic forklift, and Airforced one)

• Experience Equivalency: Additional appropriate experience may be substituted for the minimum education requirements

• License/Certifications: Requires a valid Commercial Driver's License (CDL "B") with appropriate endorsements at the time of application

• Licenses and certifications must be kept current as a condition of employment

FBI Background Check

About Everything Else

Job Profile

To view the full job profile including position specifications, physical demands, and probationary period, click here.

Position Type

Position Salary Range

Starting Pay

Agency

Assessment Requirement

The City and County of Denver provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, national origin, disability, genetic information, age, or any other status protected under federal, state, and/or local law. 

For information about right to work, click here for English or here for Spanish.

Job Description

General Summary:

The Chemistry Manufacturing Controls Manager will influence the execution of multi-product global regulatory CMC strategies for marketed products. This role contributes to the preparation and submission of regulatory CMC documentation and with interactions with Health Authorities for CMC topics. This role also provides regulatory support and guidance to various cross functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into commercial programs.

Key Duties and Responsibilities:

• Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
• Contributes to the development of global regulatory CMC strategies for commercial products
• Works with regulatory colleagues in development of global regulatory CMC strategies and submissions
• Provides regulatory CMC guidance to cross-functional teams and key stakeholders
• Influences regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
• Participates effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects

Knowledge and Skills:

• Strong interpersonal skills to exchange complex information with others and to guide others
• Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines
• Experience in the preparation, including writing, of CMC submissions
• Strategic thinking and strong problem solving skills
• Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner
• Strong sense of planning and prioritization, and the ability to work with all levels of management
• Capable of strategic thinking with ability to resolve complex and ambiguous situationsSound knowledge of cGMP, FDA, EMA, ICH

Education and Experience:

• Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
• Extensive experience in the pharmaceutical industry or related field, or the
  equivalent combination of education and experience
• Requires a high level of experience in CMC regulatory post approval variations 
   

Company Information

A production operator is someone who has the task of operating machines or tools to help the production process of a company, starting from preparing materials, making products, to the finishing stage.

1. Melakukan persiapan untuk jalan produksi (termasuk laporan, packaging, dan equipment pendukung lainya)
2. Melakukan proses CIP dan Sanitasi
3. Mengoperasikan mesin produksi
4. Melakukan pengemasan dan pengepakan sesuai standar
5. Mengisi form/laporan produksi
6. Melaksanakan dan menegakan peraturan/tata tertib perusahaan yang berlaku khususnya untuk karyawan bagian Produksi