Job Title: QC / Laboratory Lead
Site: India – Maharashtra – Nashik
Posted Date: Sep 8, 2025
Job Purpose
The QC / Laboratory Lead is responsible for ensuring the smooth functioning of laboratory operations at the site. This includes managing investigations, deviations, specifications, test methods, method validations, equipment qualifications, internal audits, and escalations. The role ensures compliance with current regulatory requirements, laboratory safety standards, and organizational values.
Key Responsibilities
Laboratory Operations & Compliance:
Lead laboratory investigations including OOS, incident investigations, and deviation management.
Authorize and approve QC documents, SOPs, and PQS related to products and RMS/PMSP for materials.
Ensure CAP/ATS compliance for instruments.
Support smooth implementation of new products at the site.
Improve analysts’ capabilities through training and mentoring.
Escalate stability failures and OOT trend situations through LIC.
Manage CAP revisions, gap assessments, and communicate changes to SOP authors.
Ensure compliance with EHS standards in QC operations.
Reduce cGMP non-compliance from L1-L4 audits and WHO inspections.
Documentation & Systems Management:
Handle and maintain electronic systems such as Empower, MERP, VQD, VQMS, SLIMS, etc.
Control SOP preparation and review schedules for QC areas.
Ensure all laboratory documentation, protocols, training records, and quality systems comply with regulatory requirements.
Conduct periodic review of instrument audit trails.
Training & Continuous Improvement:
Ensure timely training of QC personnel via OJT, Analyst Qualification, My Learning modules, and QMS training.
Drive continuous improvement in laboratory processes and defect reduction.
Prepare plans for L1 audits, track CAPA closures, and manage change controls.
Equipment & Resource Management:
Ensure calibration and qualification activities are tracked and compliant.
Reduce equipment downtime and support business continuity.
Ensure safe handling and storage of controlled substances in the QC laboratory.
Quality & Regulatory Compliance:
Verify compliance to GMP, GLP, Schedule L1 of Drugs & Cosmetics Act.
Support department head in assigned or ad hoc activities.
Ensure compliance with GPS principles (LSW, Gemba, 3Z, etc.).
Maintain QMS action items to avoid overdue actions.
Qualifications & Experience
Educational Background:
Minimum: Bachelor’s degree in Science / Pharmacy
Relevance: To understand and coordinate chemical testing activities at the Nashik site.
Experience:
Minimum 5+ years of experience in a pharmaceutical manufacturing environment.
Skills & Competencies:
Attendance management, manpower planning, and people development.
Area and critical CIF delivery management.
Completion of Level 2 audits.
Budget management and monitoring overtime (OT) compliance.
Ensure no overdue QMS actions in the department.
Why GSK?
At GSK, our values and expectations form the foundation of our culture: Patient Focus, Transparency, Respect, Integrity, Courage, Accountability, Development, and Teamwork. We prioritize innovation, performance, and trust.
Key capabilities for success:
Agile decision-making, balancing pace, rigor, and risk.
Commitment to high-quality results and overcoming challenges.
Continuous learning and skill-building.
Sustaining energy, well-being, and collaboration.
Budgeting and cost-consciousness.
About GSK:
GSK is a global biopharmaceutical company uniting science, technology, and talent to get ahead of disease together. We aim to impact the health of 2.5 billion people by the end of the decade through innovative specialty medicines and vaccines across respiratory, immunology & inflammation, oncology, HIV, and infectious diseases.
Important Notice for Employment Agencies
GSK does not accept unsolicited referrals from employment agencies without prior written authorization.
Beware of fraudulent job postings or requests for payments; GSK does not charge any recruitment fees. Report suspicious communications to askus@gsk.com.
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