GlaxoSmithKline Pharmaceuticals Ltd. (GSK Rx India) is one of the oldest pharmaceuticals company and employs over 5000+ people. Globally, we are a £ 27.4 billion, leading, research-based healthcare and pharmaceutical company. In India, we are one of the market leaders.
Post : Quality Control Executive
• Analysis of bulk samples, Finished product samples, Validation samples, water samples, Stability samples, Raw material and packaging material as per defined procedures in time as per the schedules.
• Ensure sampling testing, reporting and release of all dosage form.
• All related QC SOPs, PQS preparation and review to meets all regulatory and QMS requirements
• Follow GMP & GLP as per schedule M & L.
• To ensure adequate QC support to smooth implementation of new products at site.
• Ensure training of staff in sectional activities.
• Conduct monthly L1 audit of EHS/Quality as per schedule to identify gaps & timely closure of actions.
• Tracking of staff leave and promote for plan absenteeism. Unplanned absenteeism cases to be handle as per standard procedures.
• Encourage staff for proactively identification of unsafe condition & unsafe behavior. Report it through ZAP process.
• Build an culture of reporting safety incidents and its closure with in 10 days with appropriate CAPA.
• Drive improvement with an approach of Kaizen & CIF.
• One on one discussion with staff to maintain discipline and building their capabilities.
• Coaching/counseling of staff for adherence to standards related to safety, quality & delivery.
• Quarterly Performance discussion with staff and recording the same in PDP cards.
• Coordination & monitoring of dept consumables & inventory.
• To ensure compliance to Safety in QC areas of operation
• Reduction in the cGMP noncompliance coming from L1/L2/L3/L4 audits & WHO audits.
• Handling of Empower, BPCS,CDMS,SLIMS,MERP etc. System related to laboratory work.
• 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.
• To ensure SOPs for area are under control are valid and meets all regulatory and QMS requirements
• Support the functional head to establish the activities assigned or identified “as and when basis”.
• Embed GPS ways of working by effective utilization of GPS stds/ tools like
* Conduct Tier 1 Performance management meeting.
* Process confirmations against the 4M’s Man, Machine, Method & Material.
* Understanding & Problem solving of Top 3 issues of area.
* Actively engage team in Gemba Kaizen for continuous improvement.
* Appropriate standardization for completed improvements/change for better sustenance.
• B.Sc/M.Sc / B.Pharm/ M.Pharm (Science Graduate/ post Graduate)
• 2+ years experience in Pharmaceutical Plant
• 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 : 2+ years
Location : Nashik
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Quality Control
Req ID : 294863
End Date : 30th June, 2021
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