QA & QC Manager – Pharmaceutical Industry
Job Summary
Cosmo Pharma Pvt. Ltd. is looking for a highly experienced and dynamic QA & QC Manager to lead the Quality Assurance and Quality Control functions. The successful candidate will be responsible for ensuring compliance with cGMP, DRAP regulations, and international quality standards while overseeing all quality-related activities, laboratory operations, and quality management systems.Key ResponsibilitiesQuality Assurance (QA)
- Develop, implement, and maintain Quality Management Systems (QMS).
- Ensure compliance with cGMP, DRAP, and regulatory requirements.
- Review and approve SOPs, specifications, validation protocols, batch records, and quality documents.
- Manage deviations, change controls, CAPA, market complaints, recalls, and risk assessments.
- Conduct internal audits and coordinate regulatory inspections.
- Ensure qualification and validation activities are performed according to approved procedures.
- Monitor quality performance indicators and drive continuous improvement initiatives.
- Oversee all QC laboratory operations, including chemical, microbiological, and stability testing.
- Ensure timely testing and release of raw materials, packaging materials, in-process samples, and finished products.
- Review and approve analytical reports, specifications, and test methods.
- Ensure calibration, maintenance, and qualification of laboratory equipment.
- Investigate OOS (Out-of-Specification), OOT (Out-of-Trend), and laboratory deviations.
- Maintain laboratory compliance with regulatory and quality standards.
- Lead and mentor QA and QC teams to achieve departmental objectives.
- Coordinate with Production, Regulatory Affairs, Warehouse, and Supply Chain departments.
- Develop training programs to enhance quality awareness and compliance.
- Support business objectives through effective quality planning and risk management.
- Pharm-D, M.Pharm, MSc Chemistry, MSc Microbiology, or equivalent qualification.
- Minimum 10+ years of experience in the pharmaceutical industry.
- At least 5 years of experience in a managerial role overseeing QA and/or QC functions.
- Strong knowledge of cGMP, DRAP regulations, validation, qualification, and laboratory management.
- Experience handling DRAP inspections, customer audits, and regulatory compliance activities.
- Quality Assurance & Quality Control Management
- cGMP & Regulatory Compliance
- Laboratory Operations Management
- CAPA, Deviation & Change Control
- Validation & Qualification
- Analytical & Problem-Solving Skills
- Team Leadership & Development
- Effective Communication & Reporting
- Competitive Salary Package
- Annual Performance Bonus
- Paid Annual Leave
- Professional Development Opportunities
- Collaborative and Growth-Oriented Work Environment
Subject: Application for QA & QC Manager Position
Pay: Rs80,000.00 - Rs100,000.00 per month