Head_Quality Control_API _Chennai_Leading Pharmaceutical Manufacturing

Greetings!!!!

Job Description Head Quality Control (API)
Experience: 25+ Years
Location: Chennai
Industry: Pharmaceutical API Manufacturing
Role Type: Confidential Leadership Position

Position Overview:

We are seeking an experienced Head – Quality Control to lead the Quality Control function of an API manufacturing facility. The ideal candidate will be responsible for ensuring quality compliance, analytical operations, regulatory readiness, and continuous improvement initiatives in line with global pharmaceutical standards.

Key Responsibilities:

• Lead and manage the complete Quality Control function including Analytical Testing, Stability, Method Validation, and Laboratory Operations.
• Ensure compliance with cGMP, USFDA, EU GMP, MHRA, WHO, and other regulatory requirements.
• Oversee quality control activities for API manufacturing processes, raw materials, intermediates, finished products, and stability studies.
• Provide strategic direction for analytical method development, validation, transfer, and troubleshooting activities.
• Ensure laboratory compliance with data integrity requirements (ALCOA+ principles).
• Drive successful execution of regulatory inspections and customer audits.
• Manage deviations, OOS/OOT investigations, CAPA, change controls, and quality risk assessments.
• Review and approve analytical documents, specifications, protocols, reports, and SOPs.
• Ensure timely release of raw materials, intermediates, and finished products.
• Lead, mentor, and develop QC teams to achieve operational excellence.
• Collaborate with QA, Production, R&D, Regulatory Affairs, and Supply Chain teams for quality improvements.
• Implement continuous improvement initiatives to enhance laboratory efficiency and compliance.

Desired Candidate Profile:

• M.Sc. Chemistry / Analytical Chemistry or equivalent qualification.
• 25+ years of overall experience in Quality Control within API pharmaceutical manufacturing.
• Minimum 5+ years of experience in leading QC function as Head / Senior Leadership role.
• Strong experience in API Analytical Quality Control operations.
• Excellent knowledge of analytical instruments such as:
• HPLC
• GC
• LC-MS/MS
• GC-MS
• ICP-MS
• Dissolution & other analytical techniques
• Strong exposure to USFDA, EU GMP, WHO, and international regulatory audits.
• Proven experience in handling regulatory inspections and customer audits.
• Strong leadership, team management, and decision-making skills.
• Tamil speaking is mandatory.
• Candidates from Tamil Nadu / willing to relocate to Chennai preferred.

Note: Company details will be shared only with shortlisted candidates due to the confidential nature of the position.

Interested Candidates Kindly share your updated cv to uma@bvrpc.com