QA Supervisor

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 a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.
- It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
- How You Will Achieve It- Responsibilities:
- Lead and supervise QA Specialists for QC lab support end to end activities.
- Support reporting manager’s objectives, priorities, and metrics for the team.
- Review and approve laboratory investigations and QC deviations and change controls when and where required.
- Review and approve QC testing specification, QC testing methods, procedures, operational instructions, change controls, deviations, stability reports etc. as and when required.
- Review and approve raw material reduce testing program
- Ensure and provide guidance to QC team on Pfizer internal standards and all pharmacopoeia requirements are adhered during reviews and approvals.
- Conduct training(s) to increase knowledge and understanding of regulatory requirements, PQS, Good Manufacturing Practices (GMP) requirements and ALCOA with the team and to QC team.
- Participate and lead site teams/projects e.g., Safety, continuous improvement, manufacturing support and QA Oversight
- Work closely with Quality Operation, Production, Engineering, Warehouse and Supply chain personnel to support them in QA oversight, supply demand planning and system troubleshooting when required.
- Update and optimize QA team resources and capacity utilization.
- Develop the skills and capabilities of QA Specialists.
- Stand in for the QA Manager in his/her absence
- Engage and inspire the team on performance expectations and coach the team to meet those expectations
- Focus on Safety and GMP Compliance
- Be accountable for the Good Data Management and Data integrity principles (ALCOA) and team performance
- Lead and support continuous improvement efforts, as applicable
- EXPERIENCE
- Minimum 6 years of directly related experience in pharmaceutical manufacturing and quality operations, or equivalent combination of work experience and education.
- Related experience should be in GMP-regulated industries in in Quality Assurance Operations, Quality Control Operations, Quality Control Validation with Quality Systems knowledge such as Change Control, Deviation, CAPA and Documentation Management.
- Minimum 2 years in a supervisory capacity.
- Experience in an API manufacturing plant is preferred.
- Related experience different pharmaceutical manufacturing facilities is also preferred.

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

LI-PFE