Department: Quality Assurance / Quality Control The Quality Manager will be responsible for ensuring compliance, quality control, and regulatory adherence at third-party manufacturing facilities.

This role involves auditing and monitoring third-party manufacturers, ensuring GMP compliance, product quality, and regulatory standards are met while working closely with production, regulatory, and

supply chain teams. The ideal candidate should have a strong production background with expertise in quality assurance and control.

Key Responsibilities:

1. Quality Oversight of 3rd Party Manufacturers

- Monitor quality standards at third-party manufacturing facilities.

- Conduct regular site visits, audits, and inspections to ensure compliance with cGMP, WHO-GMP, USFDA, MHRA, and other regulatory guidelines.

- Review and approve batch manufacturing records (BMRs) and batch packaging records (BPRs).

2. Compliance & Regulatory Audits

- Ensure third-party manufacturers adhere to quality agreements, SOPs, and regulatory requirements.

- Coordinate with regulatory teams for dossier submissions, product registrations, and regulatory inspections.

- Manage deviations, OOS (Out of Specification), OOT (Out of Trend), and CAPA (Corrective and Preventive Actions) at third-party sites.

3. Quality Control & Product Testing

- Ensure raw material, in-process, and finished product testing is conducted as per standard specifications.

- Review stability studies, analytical data, and lab investigation reports.





- Collaborate with analytical labs and QC teams to ensure product quality compliance.

4. Vendor Qualification & Process Validation

- Conduct vendor qualification, supplier audits, and performance evaluations.

- Review and approve process validation, cleaning validation, and analytical method validation reports.

- Work with third-party manufacturers to optimize processes and improve product quality.

5. Documentation & Reporting

- Maintain quality agreements, technical agreements, and audit reports for third-party sites.

- Ensure all documentation aligns with GMP, ICH, and other regulatory guidelines.

- Prepare monthly quality reports, non-compliance reports, and corrective action plans.

6. Cross-Functional Collaboration

- Coordinate with production, supply chain, regulatory, and R&D; teams to ensure smooth manufacturing operations.

- Provide training to third-party manufacturers on quality standards, GMP compliance, and best practices.

Requirements

Key Requirements:

- Education: B.Pharm / M.Pharm

- Experience: 8-12 years in pharmaceutical production & quality management, with at least 3-5 years in third-party quality oversight.

- Technical Skills:

- Robust knowledge of GMP, ICH guidelines, USFDA, MHRA, and WHO-GMP compliance.

- Experience in quality audits, regulatory inspections, and vendor qualification.

- Proficiency in process validation, analytical testing, and stability studies.

- Hands-on experience with ERP systems (SAP, TrackWise, or similar) and Excel for reporting.

📌 Quality Manager – 3rd Party Manufacturing (Panchkula)
🏢 TalentXplore
📍 Panchkula