Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

The incumbent is a member of the Quality Assurance team. Under the supervision of the Senior QA Manager / Lead QA Specialist, the incumbent will be responsible for the following:

• Provide Quality Assurance oversight to site operations (primarily Production, Quality Control, Warehouse, Engineering) to ensure products produced are in compliance with Pfizer Quality Standards (PQS) and ICH guidelines.
• Work with supply chain and downstream / drug product sites to ensure timely delivery of quality products.
• Support regulatory team to file products and address regulatory queries in an accurate and timely manner.
• Understand regulatory expectations and support site inspection readiness.
• Drive quality culture and promote GMP compliant behaviours at the site.
• Drive improvement of quality systems in collaboration with cross functional teams.
• Contribute to achieve our vision of being best in class manufacturing site, producing highest quality products in the safest way.
• Deploy and use Imex "way of working" for day to day operations, problem solving, escalation and continuous improvements.

How You Will Achieve It

Responsibilities:

• Review and approve GMP documentation (e.g. GMP forms, protocols, reports, cleaning records, batch records, work instructions) to ensure their compliance with PQS.
• Disposition intermediates and active pharmaceutical ingredients (API).
• Support control and issuance of GMP controlled documentation.
• Coordinate with cross-functional team to prepare Annual Product Record Reviews, discuss trends and atypical observations and recommend improvement actions.
• Participate in process risk assessments (e.g. FMEA) as part of new product introductions and/or process changes.
• Support logistics for internal and external GMP inspections.
• Maintain inspection readiness and support inspections from regulatory agencies and customers. Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state and adhere to site procedures and PQS.
• Participate in gap analysis of site procedures against PQS and propose required actions to address identified gaps and mitigate risks.
• Maintain current quality tracking systems and quality metrics to proactively identify trends and atypical observations.
• Handle investigations according to site procedures (as required).
• Support the maintenance of validated state of GMP systems and processes.
• Uphold Pfizer's code of conduct and values.
• Play an active and impactful role in Tier processes by updating performance against metrics, highlighting & resolving issues, with appropriate escalations.
• Collaborate with cross-functional teams to drive flawless execution.
• Actively participate in Safety initiatives, and perform investigation related to EHS (as needed).

Job Related Requirements:

• Demonstrate ability to act independently to resolve issues, with appropriate escalations (as required).
• Strong verbal, written communication and presentation skills.
• Demonstrated ability to perform in a team.
• Possess a can-do / pride to succeed attitude.
• Embrace the use of digital technology to scale and speed up every form of interaction and action.

Qualifications

• Degree in Chemistry, Microbiology, Engineering or other Science related discipline.

Work Location Assignment: On Premise

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.  Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Create, review and approve Good Manufacturing Practices {also cGMP} validation documentation.
• Review and approve Manufacturing and Packaging records to ensure that the information and documentation conforms to Pfizer policy and cGMP's.
• Ensure that all documents received in the batch release area reviewed for completeness and accuracy.
• Provide Real Time Quality impact assessments and decisions on product and medical device issues, independently.
• Maintain inspection readiness, support inspections from regulatory agencies & customers and improve quality assurance systems.
• Assist and support the manufacturing/packaging staff in detecting and solving compliance errors in real time during manufacturing and packaging operations.
• Help to define appropriate action plans for improvement and follow-up and communicate action closures.

Qualifications

Must-Have

• Bachelor's Degree
• Experience in Quality administered systems
• Ability to work in a team environment within own team and interdepartmental teams
• Effective written and oral communication skills

Nice-to-Have

• Experience at a manufacturing site
• Experience of writing and managing deviations
• Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Pfizer Singapore is recruiting employees for manufacturing site expansion of PFIZER ASIA MANUFACTURING PTE LTD (PAMPL) in Singapore.

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. Your knowledge of quality control will be helpful to support our quality programs. Your ability to analyze chemical, biological or microbiological products will help us manage our quality. Your contribution to environmental testing, utility monitoring, analytical testing, microbial identification and sterility testing will help Pfizer provide safe drugs to its patients.

Your qualifications of unique Quality Control instruments will help us meet accuracy specifications for sample management, retains managements, interpretation and evaluation. You will also be relied on for establishing requirements for the transfer of methodology from R&D.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

Qualifications

Position Summary:

The incumbent is a member of the Quality Control (QC) Laboratory Systems team. Under the supervision of the QC Manager / Supervisor (Systems team), the key responsibilities are: 

·       Perform / review and document analytical testing and results accurately and in accordance to test methods, site SOPs and relevant protocols, adhering to ALCOA principles and Data Integrity (DI) requirements. 

·       Assist in troubleshooting laboratory technical problems and support laboratory investigations. 

·       Author SOPs, analytical method transfer protocols and reports and other GMP documentation (e.g. trend reports). 

·       Perform preventive maintenance or calibration of instrumentation as required, undertake housekeeping responsibilities and follow safety regulations.

·       Set up and maintain QC processes (e.g. reference standard and retention samples management)

·       Use Imex "way of working" for day to day operations, problem solving, escalation and continuous improvements.

Responsibilities:

·       Perform / review and document analytical testing and results accurately and in accordance to test methods, site SOPs and relevant protocols, adhering to ALCOA principles and Data Integrity (DI) requirements. 

·       Perform / review and document equipment verification and calibration in accordance to procedures.

·       Highlight any abnormalities detected during testing / review and raise laboratory investigations as required.

·       Support laboratory investigations and perform equipment troubleshooting where required. 

·       Participate in 5S team initiatives and practice good housekeeping, ensuring all safety procedures are followed.

·       Author SOPs, analytical method transfer protocols and reports and other GMP documentation (e.g. trend reports). 

·       Set up and maintain QC processes (e.g. reference standards and retention sample management), perform investigations as required for any associated deviations. 

·       Conduct training for fellow colleagues from QC and other departments (e.g. Production). 

·       Uphold Pfizer's code of conduct and values. 

·       Collaborate with cross-functional teams to drive flawless execution.

·       Play an active and impactful role in Tier processes by updating performance against metrics, highlighting issues, with appropriate escalations. Support development and implementation of solutions. 

·       Contribute to the continuous improvement activities in QC laboratory or cross functional teams as nominated. ​

​Job Related Requirements:

·      Effective problem solving skills. 

·      Demonstrated ability to perform in a team.

·      Knowledge of cGMPs and ALOCA principles.

·      Possess a can-do/pride to succeed attitude.

·      Embrace the use of digital technology to scale and speed up every form of interaction and action.

Must-Have

·      Bachelor's Degree in Science

·      Demonstrated technical skills in method validation and testing

·      Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations

·      Knowledge of Good Manufacturing Practices and its application standards, processes and policies

·      Excellent organizational skills and strong ability to multi-task

·      Strong written and verbal communication skills

Nice-to-Have

·      A minimum of 1 year QC experience in an analytical laboratory is preferred. 

·      Laboratory work experience with analytical HPLC (High Pressure Liquid Chromotography) Technique

·      Experience leading continuous improvement projects

·      Knowledge of lean manufacturing, six sigma methodologies, and statistics

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.