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 be relied on to make sure that they comply with the policies, procedures and practices laid down by the regulatory agencies. Your attention to detail will help us report discrepancies in product safety and recommend appropriate corrective actions. You will help the laboratory management to establish practices and procedures prior to audits.
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
- Entry environment monitoring results, water & clean steam monitoring results, oil free air monitoring results, sterility test results, etc into database and maintain the database
- Provide data trend report of environment monitoring results, water & clean steam monitoring results, oil free air monitoring results, sterility test results, etc.
- Perform verification or calibration of instruments/ equipment.
- Support chemical and physical analyses on samples from all areas of our pharmaceutical manufacturing operations and support in providing data for annual product review.
- Perform Microbiological testing of raw material, products, stability samples, in accordance with approved procedures and test methods, and record the test results in timely manner.
- Assist QC Microbiology Lab and Packaging Material Supervisor or QC Manager in laboratory investigation in case of out of specification.
- Participating in validation, and qualification program
- Perform instrument verification or calibration according to approved procedures and schedule
- Monitor that all required equipment, reagents, reference standard are always available in adequate quantity and utilized in accordance with procedures.
- Ensure all reagents, media, reference cultures, reference standards, bio-indicator are valid and stored according to requirement
- Perform microbiological method validation/ verification in accordance with the approved protocol and provide report.
- Develop or revise SOP or test procedures in Microbiology Lab.
- Perform maintenance of reference working culture in accordance to the approved procedures.
- Maintain Microbiology lab area and facilities in a clean, orderly and operational state
- Support QC Microbiology Lab and Packaging Material Supervisor or QC Manager for developing method validation/ verification protocol, study protocol, and equipment/ instrument qualification protocol.
**Qualifications**:
Must-Have
- Bachelor's Degree
- Good working knowledge of common laboratory databases
- Knowledge of regulatory compliance requirements for Pharmaceutical manufacturing
- Good analytical thinking and high-level integrity
- Able to work well either as an individual or as a team member
- Excellent interpersonal and communication skills
Nice-to-Have
- Experience in a pharmaceutical microbiology laboratory
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