Job Description:

Location: Mumbai
Function: Global TPM QA
Reporting To: Head – TPM QA, Biosimilars

About the Opportunity

This is an off-role opportunity , where you will be on the payroll of Talisman HR Solutions Pvt. Ltd.

We been associated with them  as its staffing partner for over 10+ years, supporting its recruitment and staffing requirements.

Working Details

• Working Days: Monday to Friday (5 days a week)

• Working Hours: 9:00 AM to 5:00 PM

• Work Location: Mumbai, Maharashtra

• Employment Type: Full-time, Off-role opportunity

• Payroll: Talisman HR Solutions Pvt. Ltd.
  
  About the Role

We are looking for an experienced Quality Assurance professional to manage quality oversight of Third-Party Manufacturing (TPM) sites, ensuring compliance with GMP requirements, Quality Agreements, regulatory standards, and company quality policies.

Key Responsibilities

• Provide quality oversight and monitoring of Third-Party Manufacturing (TPM) sites.

• Review and approve quality documentation, including Change Controls, Deviations, CAPA, OOS, Incidents, and Risk Assessments.

• Review market complaints and significant quality events, ensuring effective Root Cause Analysis (RCA), CAPA implementation, and timely closure.

• Review APQR and prepare PQR summaries.

• Develop, review, and maintain Quality Technical Agreements (QTA) with TPM partners.

• Conduct Quality Risk Management (QRM) and coordinate quality review meetings with TPM sites.

• Monitor TPM performance through quality scorecards, dashboards, and site assessments.

• Support First Lot Quality Reviews (FLQR).

• Represent Quality in cross-functional meetings, product launch activities, and regulatory submissions.

• Coordinate investigations and impact assessments related to temperature excursions and product quality issues.

• Ensure TPM compliance with GMP, GDP, regulatory requirements, Quality Agreements, and company quality standards.

Educational Qualification

• Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a relevant scientific discipline.

Experience & Skills

• Minimum 10 years of experience in Quality Assurance or related functions within the pharmaceutical industry.

• Experience in Third-Party Manufacturing (TPM) quality management or Supplier Quality Management preferred.

• Preferred experience in sterile dosage form manufacturing.

• Strong knowledge of GMP/GDP requirements, regulatory compliance, and pharmaceutical quality systems.

• Experience in handling deviations, CAPA, OOS, change controls, market complaints, and quality investigations.

• Excellent communication, stakeholder management, analytical, and problem-solving skills.