Assistant Manager - Hyderabad / Secunderabad
- Sanofi India Ltd
- 5 - 6 years
- Hyderabad
- 5 years ago
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Job Description
- Day to day monitoring and ensuring compliance of viral vaccines manufacturing operations with EU GMP and approved site procedures with excellent understanding on the process.
- To provide line clearance for manufacturing operations and to ensure online documentation. To be willing to work in A, B, C shifts.
- To have good technical writing and communication skills. To independently prepare investigation reports and product impact assessments in line with international regulatory expectations.
- To involve in Failure Investigations, Out of specifications, Root cause analysis (well versed with RCA tools), environmental monitoring and water excursions with knowledge on different work flow in e-tools (e-QMS, e-doc, LIMS, SAP etc.).
- Review, approval and timely closure of Quality Management System documents (Deviations, Change controls, Out of specifications, CAPA with risk assessments).
- Ensure implementation of CAPA and its effectiveness review.
- Thorough understanding on linkage / inter dependencies between different quality system elements.
- Review of SOPs, Recording sheets, Master formula records, batch manufacturing records, Protocols, Reports for Process Validation. Good understanding on simplification of complex procedures / batch records / record sheets.
- Review of Aseptic Process Simulation (APS) Protocols Reports.
- Review of executed Batch records including analytical records. Management of retention samples.
- Preparation and review of Annual Product Quality Review (knowledge on statistical analysis of data through JMP/Minitab etc.). Review of Environmental monitoring and Water trends.
- Ensuring the readiness for Regulatory inspections (EU) and Internal (Self inspection).
- To ensure the product compliance with registered dossier.
- Responsible for identification, analysis, evaluation documenting the risk and implementation of appropriate mitigation plan. Preparation of Process Risk Assessments for Viral Vaccine Manufacturing Process using FMEA / any other risk assessment tool.
Experience:
- Minimum combined 5-6years of pharmaceutical experience in a Manufacturing or Quality role.
- Previous experience on the floor in vaccine manufacturing (Cell culture, virus culture, Sterile Filtration, chromatography), exposure to aseptic environment/ aseptic practices is mandatory
- Exposure to inspections and understanding of guidelines from highly regulated market agencies like FDA, EMEA
Knowledge and skills:
- Proactive, results oriented, and a strong attention to detail.
- Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team.
- Strong organizational, analytical, and problem-solving skills
- Ability to analyse details and perform structured decision-making
- Ability to read, write, and speak English
- Excellent verbal and written communication including technical writing skills
- Good computer skills with basic knowledge of Microsoft office tools.
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: Any Graduate in Any SpecializationPost Graduation: Any Postgraduate in Any Specialization
Doctorate: Any Doctorate in Any Specialization, Doctorate Not Required
Contact Details:
Company: Sanofi IndiaLocation(s): Hyderabad
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Keyskills: Product quality Minitab SAP Manufacturing process Technical writing Analytical Pharma Risk assessment GMP Chromatography
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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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