Manager - Quality Compliance

Use Your Power for Purpose

Everything we do every day 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 customer first. 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 every step we take is aligned with our mission to improve patient outcomes. Join us in our mission to make a difference in the lives of patients through your expertise and dedication.

What You Will Achieve

In this role, you will:

Responsible for handling market complaints.

Review and approval of complaint investigation records for thoroughness, accuracy and compliance to standards.

Ensure investigations are closed within requirements.

Provide direct input or coaching support for other functional groups in complaint investigations.

Manage complaint investigations and apply relevant and necessary actions/systems.

Issue Notification to Management (NtM) for any issues related to product quality, compliance or market actions.

Provide inputs for timely management of field alert reports or market actions.

Prepare and execute Mock recall protocols

Preparation of APQRs as per approved schedule

Evaluate data, trends and report results to manager.

Co-ordinate the execution of market action and maintain the record.

Support Internal/customer regulatory audits

Present the information/data/document as necessary for complaints and APQR during audit/inspection.

Know the processes and procedures, including the principles and practices of good data management (ALCOA), and be able to guide, advise and coach the team.

Be accountable for the Good Data Management and Data integrity understanding and performance of the team.

Effectively monitor the actions of the team. Ensure an active daily presence in the GMP work area to observe the work activity and practices.

Present the information/data/document as necessary for complaints, APQRs, Market actions during audit/inspection.

Act as an SME for Product Complaints and APQRs.

Here Is What You Need (Minimum Requirements)

B.Pharm / M.Pharm / M.Sc.

Preferably 10+ years of experience in Quality Assurance in sterile manufacturing facility.

Knowledge of performing product complaint analysis and investigations.

Current regulatory compliance expectations (India FDA, USFDA, MHRA, EMEA, TGA etc.

Through knowledge of GMPs

Knowledge of various quality tools for investigations

Experience in quality systems of sterile product manufacturing.

Should have good technical writing skills

Preferably having experience in good understanding of quality systems

Bonus Points If You Have (Preferred Requirements)

Autonomous approach to work.

Persistent approach to resolving issues.

Strong time and self-management skills

Demonstrates leadership. Ability to provide customer focused flexible leadership.

Rapport and relationship development.

Compliance driven approach-Good Working knowledge of GMP and pharmaceutical regulations.

Effective project management skills and demonstrated ability to manage multiple completing priorities.

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

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