Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety.
Responsible for implementing and maintaining the quality systems and ensuring compliance throughout end-to-end manufacturing operations
Responsible for inspection readiness activities and ensuring all the manufacturing processes are in compliant with Pfizer policies and regulatory guidelines
Prepare and maintain Quality Risk Assessments for equipment and processes.
Track implementation of mitigation plans and ensure timely closure of identified risks.
Prepare, review, and approve Master Manufacturing Records (MMRs) and Master Packing Records (MPRs) for commercial, scale-up, exhibit, intended, and process validation batches.
Ensure all documentation complies with GDP and ALCOA principles.
Initiate Change Control Forms (CCFs), coordinate with cross-functional teams for impact assessment, and manage pre-approval and closure.
Update procedures as per approved CCFs and ensure timely upload in PLS.
Monitor and track action items related to CCFs for closure within defined timelines.
Prepare responses to audit observations and propose CAPAs in consultation with SMEs, owners, and QA.
Track CAPA implementation and provide regular updates to stakeholders.
Support investigations and ensure timely closure of CAPAs and commitments.
Review and approve SOPs, job aids, and SOJTs in PDOCS as primary or secondary owner.
Prepare, review, and execute protocols and user requirement specifications.
Manage classified area access for colleagues, contingent workers, and service providers.
Review and approve alarm reports, conductivity reports, NVPC trend reports, and APQR reports.
Verify NVPC monitoring activities and perform assessments of PQS, CAS, and compendial requirements.
Establish alert and action levels for Environmental Monitoring.
Prepare, review, and approve cross-contamination strategy documents and PCER documents.
Deliver Instructor-Led Training (ILT) sessions to colleagues and service providers as required.
Participate in regulatory and RQA audits and ensure compliance with applicable standards.
Ensure document management and walkthrough compliance.
Maintain adherence to GDP and ALCOA principles in all documentation and processes.
