Quality Control Lead - Job Description
Location: Nashik, Maharashtra, India
Posted On: February 10, 2025
Role Overview
The Quality Control (QC) Lead is responsible for ensuring compliance with Good Laboratory Practices (GLP) and overseeing key quality processes, including internal audits, laboratory investigations, environmental health and safety (EHS), and risk management. The role also involves supporting the production department by ensuring the timely release of raw materials, finished products, stability samples, validation processes, and packaging materials.
Key Responsibilities
- Supervise and ensure the testing and release of raw materials, excipients, packaging materials, microbiological samples, bulk, and finished products.
- Oversee the execution of stability programs according to established protocols.
- Support the validation team in managing process validation sample analysis.
- Ensure proper qualification, calibration, and maintenance of laboratory instruments.
- Lead investigations and timely reporting of Out of Specification (OOS) results.
- Manage laboratory-related SOPs, PQS, and PMSP, ensuring regular reviews.
- Oversee reference standards management for QC laboratories.
- Ensure compliance with Corrective and Preventive Actions (CAPA) and Audit Tracking Systems (ATS).
- Maintain QC lab compliance with regulatory and inspection requirements.
- Verify adherence to Good Laboratory Practices and Schedule L1 of the Drugs and Cosmetics Act.
- Conduct initial assessments for change control within the operational scope.
- Conduct monthly EHS and quality audits, addressing gaps and ensuring timely resolution.
- Reduce current Good Manufacturing Practice (cGMP) noncompliance identified in internal and external audits.
- Manage staff leave and address absenteeism as per standard procedures.
- Foster staff engagement through one-on-one discussions, performance reviews, and capability-building initiatives.
- Provide coaching and counseling to ensure adherence to safety, quality, and delivery standards.
- Conduct quarterly performance evaluations and record progress in PDP cards.
- Monitor and manage departmental consumables and inventory.
- Oversee electronic systems, including Empower, MERP, VQD, VQMS, and SLIMS.
- Optimize resource management to ensure smooth laboratory operations.
- Ensure timely procurement of quality department requirements.
- Act as the Site SQCS contact, supporting vendor approvals and purchase sample analyses.
- Conduct QMS training and perform gap analyses to maintain compliance.
- Manage SOPs to ensure regulatory and QMS compliance.
- Implement risk management strategies, tracking logs, and STP preparation.
- Lead monthly EHS meetings to address and resolve safety concerns.
- Encourage proactive identification and reporting of unsafe conditions through the ZAP process.
- Maintain control over chemical reagents and hazardous substances, including biological agents.
- Promote a culture of safety reporting and timely incident resolution with CAPA implementation.
- Support EHS activities within the Quality Control department.
- Prevent first-aid cases and workplace accidents through proactive safety measures.
- Drive compliance with GPS principles (LSW, Gemba, 3Z) and promote continuous improvement via Kaizen and CIF methodologies.
- Foster a culture of continuous learning and quality improvement within the laboratory.
- Provide authorization and approval for QC documents.
- Ensure safekeeping and management of controlled substances in the QC laboratory.
- Assist the functional head with assigned activities on an as-needed basis.
Scope of Accountability
- Managing attendance and workforce planning.
- Leading people development initiatives.
- Overseeing manpower planning and area management.
- Delivering site-critical CIF objectives.
- Ensuring timely completion of Level 2 audits.
- Meeting departmental budget goals.
- Maintaining overtime (OT) within the set quarterly limits.
- Ensuring timely completion of all QMS actions.
Qualifications and Experience
Educational Background:
- M.Sc / B.Pharm / M.Pharm
Experience Requirements:
- 12-15 years of experience in a pharmaceutical manufacturing plant, with at least 10 years in QC.
- Strong understanding of pharmaceutical quality control and regulatory compliance.
- Advanced proficiency in computer software applications.
- Excellent leadership and resource planning skills.
- Strong problem-solving and communication abilities.
- Ability to build and maintain cross-functional relationships.
Equal Opportunity & Ethical Hiring
At GSK, we are committed to fostering an inclusive workplace that values diversity, including gender, LGBTQ+, and PwD (Persons with Disabilities). We ensure a fair hiring process for all candidates.
Important Notice: GSK does not charge any recruitment fees. Beware of fraudulent individuals or entities claiming to represent GSK and requesting payments for job applications. Any such claims should be ignored, as GSK does not request money for recruitment processes at any of its locations worldwide.