Quality Control Manager
2 weeks ago
Job Title: Quality Control Manager – Pharmaceuticals
Company: Concord Drugs Limited
Location: Hyderabad
Department: Quality Control
Experience Required: Minimum 15 years (with at least 5 years in a managerial role)
Employment Type: Full-time
Job Description:
We are seeking a highly experienced and knowledgeable Quality Control Manager to lead our QC department in a regulated pharmaceutical formulation manufacturing facility.
The ideal candidate should have extensive experience in handling audits such as WHO-GMP, EU-GMP, UK-MHRA, and USFDA, with in-depth understanding of Revised Schedule M requirements.
Key Responsibilities:
- Oversee and manage all Quality Control activities for raw materials, in-process samples, finished products, and stability testing.
- Ensure all QC operations comply with cGMP, Revised Schedule M, and global regulatory standards.
- Supervise analytical testing, instrument calibration, and documentation practices as per ALCOA+ principles.
- Review and approve analytical data, COAs, and laboratory records.
- Ensure readiness and compliance for audits by WHO, EU, UK-MHRA, and USFDA authorities.
- Coordinate with QA, Production, and R&D to ensure consistent product quality and regulatory compliance.
- Drive implementation of laboratory automation and data integrity systems.
- Lead, train, and develop QC team members to maintain operational excellence.
- Prepare and review SOPs, method validation protocols, and investigation reports.
- Monitor OOS/OOT results, CAPAs, and ensure timely closure of quality events.
Desired Candidate Profile:
- Qualification: M.Sc / B.Pharm / M.Pharm (Analytical Chemistry / Pharmaceutical Sciences preferred).
- Experience: Minimum 15 years in Quality Control, with strong exposure to international regulatory audits.
- Strong knowledge of analytical instruments (HPLC, GC, UV, IR, Dissolution Tester, etc.).
- Comprehensive understanding of Revised Schedule M and global GMP guidelines.
- Proven ability to manage teams and ensure compliance under pressure.
- Excellent communication, leadership, and audit-facing skills.
Job Type: Full-time
Pay: ₹50, ₹80,000.00 per month
Work Location: In person
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