Senior QA Specialist (Investigations)

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.

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

Position Summary

The incumbent is a member of the Quality Assurance (QA) Operations team. Under the supervision of the Senior QA Manager the incumbent will be responsible for the following:

• Provide Quality Assurance (QA) oversight of Good Manufacturing Practice (GMP) investigations including manufacturing and laboratory investigations to ensure products comply with Pfizer Quality Standards (PQS) and International Council for Harmonisation (ICH) guidelines.
• Serve as the local process owner for investigation-related quality systems including Nonconformance Corrective and Preventive Actions (CAPA) and Management / Board of Health Notifications.
• Maintain awareness of regulatory expectations and support site inspection readiness.
• Promote a strong quality culture and GMP-compliant behaviours at the site.
• Drive quality system improvements in collaboration with cross-functional teams.
• Contribute to the site vision of being a best-in-class manufacturing site that produces high-quality products safely.
• Apply the IMEx way of working to day-to-day operations problem solving escalation and continuous improvement.
• Mentor QA team members including training QA approvers for investigations.

How You Will Achieve It

• Provide QA oversight of GMP investigations including manufacturing and laboratory investigations; issue Management Notifications; and implement batch controls related to investigations such as batch holds and quarantine notifications.
• Review and approve GMP records associated with investigations including investigation reports manufacturing records related to investigation actions CAPA and effectiveness checks in accordance with site procedures. Ensure that root cause analyses corrective and preventive actions and quality validation stability and regulatory impact assessments are adequate. Escalate issues as required.
• Serve as the local process owner for investigation-related quality systems including site representation at global Process Centric Teams (PCTs) and authoring related site procedures and documentation.
• Serve as site trainer for investigation-related roles and system access such as QA approver for investigations.
• Perform Designated Point of Contact (DPOC) and super-user responsibilities for assigned site platforms supporting quality systems such as TrackWise and Vault QMS as nominated.
• Prepare periodic review reports analyze trends recommend improvement actions and monitor relevant metrics to ensure investigation-related quality systems remain in a state of control.
• Conduct or support market actions related to investigations including mock recalls as required by procedures.
• Apply quality risk management (QRM) principles to support risk assessments and mitigation actions.
• Maintain inspection readiness and support inspections by internal auditors regulatory agencies and customers. Participate in GMP walkdowns to verify that site operations and facilities remain inspection-ready and comply with site procedures and PQS.
• Support maintenance of the validated state of GMP systems and processes.
• Uphold Pfizers Code of Conduct and values and demonstrate Pfizers actionable attributes.
• Actively participate in Tier processes by updating performance against metrics highlighting and resolving issues escalating appropriately and implementing solutions.
• Mentor junior QA team members including interns.
• Participate in safety initiatives and perform Environmental Health and Safety (EHS)-related investigations as needed.

Job Related Requirements

• Ability to act decisively and independently to resolve issues with appropriate escalation as required.
• Ability to work effectively in a team and mentor junior team members.
• Demonstrates a proactive mindset and commitment to delivering high-quality outcomes.
• Adopts digital technology to improve the speed scale and effectiveness of interactions and actions.

Qualifications and Experience

• Degree in Chemistry Microbiology Engineering or other Science related discipline.
• Minimum of 4 years of experience including QA experience within the pharmaceutical industry.
• Compliance regulatory or validation experience is an advantage.
• Strong written and verbal communication skills; technical report writing experience is an advantage.
• Demonstrated personal leadership accountability and organizational skills with proven ability to operate independently with minimal supervision. Experience working in a cross-functional matrix environment is an advantage.

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

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