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 : FLL laboratory
He/She is accountable for the following activities;
• SLIMS Deployment and support for SLIMS operations at all sections of QC labrotory .
• Support to the production department to meet the manufacturing schedules by timely release of Raw materials/packaging material/ finished products/Bulk testing/Stability testing.
• GLP compliance, internal audits, Lab Investigations, Lab Safety, EHS, and Risk management related to Quality department and Values & expectation of the Organization.
• To ensure adequate QC support to smooth implementation of SLIMS at site.
• Ensure sampling, testing, reporting and release of Raw materials/packaging material/ finished products/Bulk testing/Stability testing.
• All related QC RMS,SOPs, PQS preparation and review to meets all regulatory and QMS requirements
• Carrying out the gap analysis and compliance as per the ATS,CAP, GQP and GQMP
• Control on UK reference standard management require for QC laboratory
• Follow GMP & GLP as per schedule M & L.
• Ensure training of staff in sectional activities.
• Conduct L1/L2 audit as per the schedule.
• To ensure compliance to Safety in QC areas of operation
• Ensure compliance to GPS principles (LSW, Gemba,3Z etc)
• Coaching/counseling of staff for adherence to standards related to safety, quality & delivery.
• Coordination & monitoring of dept consumables & inventory.
• Reduction in the cGMP noncompliance coming from L1/L2/L3/L4 audits & WHO audits.
• Handling of electronic systems (e.g. Empower,MERP, VQD, VQMS, SLIMS etc.)
• Handling of incidence,deviation,OOS,and CAPA management.
• 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.
• Review of all analytical reports.
• To ensure the QC personnel completed the OJT/Analyst Qualification /My Learning modules and QMS training in time.
• Support the functional head to establish the activities assigned or identified “as and when basis”.
• M.Sc /B.Pharm/ M.Pharm (Science Graduate/post Graduate)
• 5+ years expirence in Pharmaceutical Plant
Other Job-Related Skills/Background
• Advanced knowledge of computer software & potency in use of computer software (Word, Excel, Powe Point).
• Resource Planning
• Problem Solving
• Effective communication skills
• Ability to build relationships (Team building ) at all levels and across functions.
• Have Influencing skilled & IR issue handling.
Experience : 5+ years
Qualification : M.Sc / B.Pharm / M.Pharm
Location : Nashik
Industry Type : Pharma / Healthcare/ Clinical research
Functional Area : Quality
End Date : 10th August, 2023
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