Quality Manager – 3rd Party Manufacturing

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:
  
• Strong 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.