Associate Manager-Manufacturing Compliance

Use Your Power for Purpose

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.

What You Will Achieve

Use Your Power for Purpose

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.

What You Will Achieve

You will be responsible for activities involved in developing and maintaining programs, processes and procedures that ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in commitments tracking, interpreting policies, manage site complaints and work directly with operating entities to provide process analyses oversight.

In this role, you will:

• 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.

Here Is What You Need (Minimum Requirements)

• Master’s degree/bachelor's degree in pharmacy with 8+ years of experience preferably in Manufacturing or Quality Assurance department in a sterile Injectable manufacturing site.

• Must have extensive exposure to manufacturing operations, IPQA activities, QMS activities and inspection readiness

• Strong understanding of USFDA regulatory requirements and compliance standards.

• Excellent attention to detail and organizational skills.

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

• Effective written and verbal communication skills.

• Skills with Lean six sigma tools

Bonus Points If You Have:

• Demonstrated working knowledge and understanding of sterile injectable manufacturing procedures and processes

• Knowledge of Good Manufacturing Practices {also cGMP}, validation, audit techniques, and working knowledge of statistics

• Experience with audit processes and corrective action plans.

• Strong problem-solving skills.

• Knowledge of drug product requirements

 
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