Teva Opening for Quality Assurance Manager
Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas.
Post : Manager Quality Assurance
Maintaining a Quality assurance system in according with up-to-date requirement of the regulatory authorities. Maintaining a set of procedures that support the Quality assurance system. Responsible to release / reject the material / batch includes the review and approval of related manufacturing and analytical documents. Review, approval and maintaining of the documents / master documents related to monographs, Validation master plan, site master file, Laboratory information file, SOP’s, equipment qualification, general system validation, batch cards, process validation, cleaning validation and other production related data.
• Basic GMP, refreshing GMP/ data integrity training & SOP training to all company employees and contract workers.
• Handling of customer and regulatory inspections, Audit Compliance report and related CAPA and follow up, Plant QA round for monitoring GMP compliance.
Handling of customer queries and complaints & Change control Management.
• Carrying out quality system audits / internal audit to verify compliance with principles of GMP.
• Coordinating in investigation and closing of deviation, LIR, OOT and OOS results and market complaints. Follow up and implementation CAPA with effectiveness verification.
• Review and verification of documents and update in computerized system.
Coordination in vendor qualification and approval activities.
• Coordination for preparation of Approved manufacturer / vendor list.
Performing vendor / service provider audits as and when required.
• Review and archival of technology transfer documents and Performing tech transfer / site transfer activities as per Teva policy.
• Stability sample initiation for validation batches, annual batch and others.
• As an Opex champion, identification of improvement projects in respective areas and supporting functional head to implement the project with targeted OTIF.
• Estimating the base line performance and implementation of OPEX in respective areas to achieve the targeted continuous improvement in cost, quality, compliance and EHS.
• Monitoring and review of energy consumption in respective areas and initiating the CAPA if it is out of trend/off the track.
• Responsible for assisting Site QA Head for implementation of QA activities in plant and approving all related documents as a proxy to Site QA Head.
• 12+ years’ experience in QA with 7+ years’ experience in QMS.
• Should be MSc Chemistry/B Pharma/M Pharma/Bio-Analytical
• Should have experience in Track Wise, LIMS, ERP
Experience : 5+ yrs
Qualification : M.Pharm, B.Pharm, M.Sc
Location : Gajraula, India
Industry Type : Pharma/ Healthcare/ Clinical research
Job ID : 244235
End Date : 30th December, 2023