Work as Lab Compliance Lead at GSK

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Post : Lab Compliance Lead

Job Description
Accountable for the following activities ;
• Supports to the Laboratory functions to handle Investigations, Deviation Management, Specifications ,test methods, method validations equipment qualifications ,internal audits and escalations if any.
• Support to the Laboratory functions to meet compliance as per current requirements.
• Internal audits, GLP compliance, Lab Investigations, Lab Safety, Risk management related to Quality department and Values & expectation of the Organization.

Key Responsibilities
• To lead laboratory investigation through OOS, incident investigations and deviation management.
• To provide authorization/approval of QC documents.
• All related QC SOPs, PQS for product and RMS,PMSP for material preparation and review.
• 100% CAP/ATS compliance for Instruments.
• To ensure adequate QC support to smooth implementation of new products at site.
• Improve capability of analysts.
• To escalate the stability failure, OOT trend situation through LIC.
• Management of CAP revisions gap assessments and change communication to respective SOP author.
• To ensure compliance to EHS in QC areas of operation.
• Reduction in the cGMP noncompliance coming from L1/L2/L3/L4 audits & WHO audits.
• Handling and maintenance of electronic systems (e.g. Empower,MERP, VQD, VQMS, SLIMS etc.)
• Control on Lab. Related SOPs Preparation and Review as per the schedule.
• To ensure continuous improvement in laboratory working and to impart training to QC staff.
• Drive improvements with respect to defect reduction in laboratory.
• Prepare plan for L1 audit for QC with related documents and follow-up action of CAPA closure and change control.
• Verify compliance to GMP,Good Laboratory practice and Schedule L1of D & C act
• To ensure the training compliance of QC personnel with the OJT/Analyst Qualification /My Learning modules and QMS training in time.
• To ensure SOPs for area are under control are valid and meets all regulatory and QMS requirements
• Control and maintenance of documents including the quality systems as per the requirement of regulatory authorities which involves all raw data, SOPs, documentation exhibits, Protocols, training.
• To ensure instrumental audit trail program reviewed and documented periodically.
• To ensure compliance requirements and inspection readiness.
• Support the department head to establish the activities assigned or identified “as and when basis”.
• Ensure compliance to GPS principles (LSW, Gemba,3Z etc)
• Reduce downtime of equipments and support for business continuity.
• Ensure calibrations and qualification activities are tracked and maintain compliance.
• To ensure safekeeping of controlled substances in the QC laboratory.

Candidate Profile
Area of Specialisation - Science/Pharmacy
5+ years experience in Pharmaceutical Plant

Additional Information
Experience : 5+ years
Qualification : Science/Pharmacy
Location : Nashik
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th September 2025