Job Description

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 dedicated and highly effective quality control team. Your knowledge of quality control will be helpful to support our quality programs.

Under the supervision of the QC Supervisor (System), you will be responsible for ensuring appropriate laboratory support in terms of equipment availability and system readiness to the QC Operation team to support manufacturing operations. You will also assist in the management, support and troubleshooting of key laboratory systems such as gLIMs and Empower, systems periodic DI evaluation, Retain Sample management in gLIMS, and equipment validation where required.

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

• Provide timely support to the site in gLIMs master data creation / modification.
• Provide timely support to the site in Empower project administration/ customize report.
• Perform audit trial/ periodic DI review of QC equipment/ system where required.
• Assist in the administration for computerized system where required.
• Advise on the systems troubleshooting and follow up with appropriate course of action.
• Work closely with Lab Operation, QA, Supply Chain and Production personnel to support them in any troubleshooting when required.
• Assist in Retain sample management-gLIMS related.
• Perform equipment qualification and validation where required.
• Perform equipment verification and calibration in accordance to procedures where required.
• Perform maintenance and troubleshooting of laboratory equipment where required.
• Write and/or update Standard Operating Procedures (SOPs) for the laboratory.
• Ensure all documentation and quality records are conducted in accordance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements and that they are filed in accordance with existing policies.
• Follow the ALCOA principles.
• Review reports and ensure that all laboratory documents are in a constant state of regulatory compliance and inspection readiness.
• Train fellow colleagues on written procedures, SOPs and on the job training
• Conduct investigations/incidents, identify root causes and implement appropriate corrective action and preventive measures.
• Participate actively and contribute to site project teams.
• Actively participate in Safety initiatives, typically a role model for other analyst. Ability to perform investigation related to EHS.
• Participate in 5S team initiatives and practice good housekeeping.
• Close coordination with cross function colleagues / Vendors to achieve desire outcome (e.g. Lab equipment installation/ Validation/ Service contract).
• Commitment to work and positive influencer/role model/motivate others for overall operational excellence.

Qualifications

Must-Have

• Degree or Diploma (preferably Chemistry) or Chemical Process Technology.
• Degree or Diploma in Information System with experience in pharmaceutical industry.
• Degree or Diploma in Computer System Engineering with interest and familiarity in health informatics in pharmaceutical industry.
• Minimum of 3 years (for Degree) or 5 years (for Diploma) of QC experience.
• Knowledge of Good Manufacturing Practices and its application standards, processes and policies.
• Knowledge of LIMS, Empower, HPLC, GC, laboratory equipment.
• Excellent organizational skills and strong ability to multi-task.
• Demonstrated leadership and customer service skills.
• Effective problem-solving skills.
• Strong verbal, written communication and presentation skills.
• Demonstrated ability to perform in a team.
• Data Integrity and ALCOA understanding.

Nice-to-Have

• Laboratory work experience with LIMS/Empower/SAP at administrator level.
• Laboratory work experience with systems periodic DI evaluation/ audit trail review.

Work Location Assignment: Flexible

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

Quality Assurance and Control

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Pfizer