Assistant Manager - Hyderabad / Secunderabad
- Sanofi India Ltd
- 5 - 6 years
- Hyderabad
- 5 years ago
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Job Description
Job description
Health, Safety and Environment
- Reporting for any unsafe conditions and incidents to HOD HSE.
- To ensure adherence to safety procedures and Instructions.
- To ensure incident reporting, lead investigations and CAPA implementations.
Sterility Assurance
- Provide guidance and support to customers related to bulk manufacturing suites in sterility assurance programs.
- Review of facility layouts and involve in the technical discussions pertaining to the same.
- Review sterilization validation (Moist/Dry heat) and facility qualification protocols.
- Review water system and performance qualification protocols and reports.
- Review sterilizing grade filter validation protocols and reports.
- Review clean room entry/exit practices in compliance with environmental zoning.
- Maintain database for sterility assurance activities and tracking the progress.
- Analyze environmental monitoring and clean utility monitoring trends periodically.
- To participate and assist where required in internal/external audits of sterile processes.
- Investigate deviations/excursions and review deviation/excursion reports.
- Perform gap analysis for the practices employed in the site against the global standards.
- Maintain inspection readiness activities during inspections.
- Responsible for identification, analysis, evaluation documenting the risk and ensuring the implementation of appropriate mitigation plan.
- Responsible for approving risk assessment, Performing risk review and documenting the same.
Quality Management System
- Evaluation of the change control in the PHENIX.
- Evaluation and Approval of the CAPA in the PHENIX.
- Implementation of CAPA related to sterility assurance.
Documentation
- Write, review, approval of standard operating procedures related to sterility assurance function.
- Review and approval of aseptic process simulation protocols, Execution records and preparation of APS summary reports.
- Prepare, review, approval of Environmental monitoring trends and summary reports.
- Write and review change control forms to assess the impact of proposed changes.
- Approval of standard operating procedures of user departments related to sterility assurance.
External Audits/Inspections:
- Ensure the site is all time readiness for audits in sterility assurance aspect.
- Actively involve global quality audit, regulatory inspections and develop responses/CAPA for audit findings/observations by coordinating with cross functional departments.
Trainings
- To impart the trainings associated to Sterility Assurance.
Job Classification
Industry: Pharma, Biotech, Clinical ResearchFunctional Area: Production, Manufacturing, Maintenance,
Role Category: Production/Manufacturing/Maintenance
Role: Production/Manufacturing/Maintenance
Employement Type: Full time
Education
Under Graduation: B.Sc in ChemistryPost Graduation: MS/M.Sc(Science) in Chemistry
Contact Details:
Company: Sanofi IndiaLocation(s): Hyderabad
Keyskills: Assurance External audit Risk assessment Quality audit Standard operating procedures Gap analysis HSE Environmental monitoring Water system Auditing
Sanofi India Ltd
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the...
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