Quality Control Manager
12 hours ago
Job Title: Quality Control Manager Pharma
Industry: Pharmaceuticals
Functional Area: Quality Control
Role Category: Quality Control Manager
Job Location: Sterling Healthcare Ltd., Talegaon, Pune
Employment Type: Full-Time
Experience Required: 5– 10 Years
Job Description
Sterling Healthcare Ltd. is seeking an experienced Quality Control Manager to lead and manage Quality Control laboratory operations in a pharmaceutical manufacturing environment. The role is responsible for ensuring product quality, regulatory compliance, and adherence to GMP and global quality standards.
Key Responsibilities
- Manage and oversee day-to-day operations of the Quality Control laboratory
- Ensure testing of raw materials, packaging materials, in-process samples, finished products, and stability samples as per approved specifications
- Review and approve analytical test results, Certificates of Analysis (COA), SOPs, protocols, and analytical reports
- Ensure compliance with cGMP, GLP, WHO, FDA, ICH guidelines, and pharmacopeial standards (USP, EP, IP, BP)
- Investigate and manage OOS, OOT, deviations, change controls, and CAPA
- Support and participate in regulatory inspections, customer audits, and internal audits
- Oversee analytical method validation, verification, and method transfer activities
- Ensure calibration, qualification, and preventive maintenance of laboratory instruments
- Monitor and manage stability studies in compliance with regulatory requirements
- Lead, train, mentor, and develop Quality Control team members
- Ensure data integrity (ALCOA+) and adherence to proper documentation practices
Key Skills & Competencies
- Pharmaceutical Quality Control
- GMP / GLP Compliance
- Analytical Techniques: HPLC, GC, UV, IR, Dissolution
- OOS / OOT / Deviation / CAPA Handling
- Analytical Method Validation & Transfer
- Stability Studies
- Regulatory Audits (FDA / WHO)
- Team Management & Leadership
Education & Qualification
- M.Pharm / MSc (Chemistry / Analytical Chemistry)
Experience
- 5–10 years of experience in Pharmaceutical Quality Control
- Minimum 3–5 years in a managerial or supervisory role
- Prior experience handling regulatory inspections is preferredRole & responsibilities
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