Use Your Power for Purpose
Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is flexible, innovative, and customer-oriented. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a real difference in the lives of those we serve. Join us in our mission to improve patient outcomes through excellence in every aspect of our work.
What You Will Achieve
In this role, you will:
- Lead the Process Microbiology Team (Environmental Monitoring Team)
- Understanding of pharmaceutical manufacturing, packaging, and quality assurance operations in sterile manufacturing facility.
- Experience in MLT, BET and Sterility.
- Expertise in Testing – MLT, BET, Sterility, and samples for Environmental Monitoring.
- Experience in overall management and operations of Microbiology Lab, with special emphasis to clean room / sterility testing area.
- Knowledge of handling media, cultures and LAL test kit.
- Experience of participation in aseptic process simulation, qualification of clean rooms and critical areas.
- End to end of Area Qualifications and routine EM process
- Capable of handling failure investigations for sterility, positive media fill, unusual trends in EM and water samples, with Analytical thinking, arriving at RCA and suggesting CAPA.
- Knowledge of qualification and operation of commonly used equipment in microbiology lab – autoclave, incubators, LAF, etc.
Here Is What You Need (Minimum Requirements)
- 12+ years relevant Pharmaceutical Industry Experience
- Strong background in Quality Control Microbiology
- Extensive knowledge of Good Manufacturing Practices (cGMP) compliance requirements for Quality Control Laboratories
- Proficiency in a wide range of analytical techniques and Process Microbiology Requirements
- In-depth understanding of aseptic processing and monitoring procedures
- Strong reasoning abilities, including analytical and problem-solving skills
- Significant people management experience
Bonus Points If You Have (Preferred Requirements)
- Master's degree
- Knowledge in the application of statistical tools, root cause analysis, and/or six sigma methodologies
- Experience with environmental testing, utility monitoring, analytical testing, microbial identification, and sterility testing
- Expertise in Quality Control (QC) instruments and accuracy specifications
- Experience in setting requirements for the transfer of methodology from Research and Development (R&D)
- Ability to manage projects and ongoing work activities of moderate complexity
- Excellent verbal and written communication skills
- Ability to foster teamwork and colleague development
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.
Quality Assurance and Control