Quality Control Lead Position at GSK, Apply Online
Quality Control Lead
Nashik, India
Quality
407714
Job Description
Site Name: India – Maharashtra – Nashik Site
Posted Date: Oct 28, 2024
Job Purpose
Accountable for:
- GLP compliance, internal audits, lab investigations, lab safety, EHS, and risk management related to the Quality department.
- Upholding the values and expectations of the organization.
- Supporting the production department to meet manufacturing schedules by timely release of raw materials, finished products, stability, validation, and packaging material testing.
Key Responsibilities
- Ensure testing and release of raw materials, excipients, packing material, microbiological samples, bulk, and finished products.
- Oversee stability program conducted as per protocol.
- Support validation team for process validation sample analysis and management.
- Ensure qualification, calibration, and maintenance of all laboratory instruments.
- Conduct OOS investigations and timely reporting.
- Manage lab-related SOPs/PQS/PMSP reviews as per schedule.
- Oversee reference standards management required for QC laboratories.
- Ensure CAP/ATS compliance.
- Maintain QC lab activities in line with regulatory requirements.
- Ensure compliance and inspection readiness.
- Verify compliance with Good Laboratory Practice and Schedule L1 of the D&C Act.
- Conduct initial assessment of change control raised in the area of operation.
- Conduct monthly L1 audit of EHS/Quality as per schedule to identify gaps and ensure timely closure of actions.
- Reduce cGMP non-compliance issues from L1/L2/L3/L4 and WHO audits.
- Track staff leave, encourage planned absenteeism, and manage unplanned cases per standard procedures.
- Hold one-on-one discussions with staff to maintain discipline and enhance capabilities.
- Coach and counsel staff for adherence to safety, quality, and delivery standards.
- Conduct quarterly performance discussions with staff and record NMS performance in the PDP card.
- Coordinate and monitor department consumables and inventory.
- Manage electronic systems (e.g., Empower, MERP, VQD, VQMS, SLIMS).
- Ensure timely procurement for quality department needs.
- Act as Site SQCS contact and ensure QC support in vendor approval and purchase sample analysis.
- Complete QMS training on time and ensure QMS compliance within your operational area.
- Ensure area SOPs meet regulatory and QMS requirements.
- Perform risk management, control risk log, and track risks with STP preparation.
- Conduct monthly EHS meetings to discuss and resolve issues.
- Encourage staff to proactively identify unsafe conditions and behaviors, reporting through the ZAP process.
- Control chemical reagents and special hazards, including sensitizers and biological agents.
- Promote a safety culture in the Quality Control department.
- Participate in RCAs as required.
- Ensure compliance with GPS principles (LSW, Gemba, 3Z).
- Drive improvements with Kaizen and CIF approaches.
- Continuously improve laboratory operations and support QC staff performance.
- Assist the functional head with assigned activities as needed.
- Approve QC documents as required.
- Oversee safekeeping of controlled substances in the QC laboratory.
Scope of Accountability
- Testing and reporting activities in the QC laboratory at the Nashik site.
- Attendance management, people development, manpower planning, and area management.
- Deliver site-critical CIF and complete Level 2 audits.
- Adhere to department budget, maintaining quarterly OT within 105 hours.
- Avoid overdue QMS actions within the department.
Job-Related Skills/Background
- Advanced knowledge of computer software and proficiency in its use.
- Leadership and resource planning skills.
- Strong problem-solving and effective communication skills.
- Ability to build team relationships across levels and functions.
Link to Original Notification to apply: Apply Here
Keywords: Quality Control Lead, Nashik, India, Job Posting, GSK, Compliance, Safety, Quality, GLP, EHS, Risk Management. Quality Control Lead Position at GSK, Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.