About Sanofi
The firm is an MNC distributed over more than 80 countries serving more than 200 million people. The company working on patient centric giving efforts to produce the high standard medicines. The firm is based on Israel and works mainly on generics. The company have a strong background of Research & Development that is continuously improving which is patient centric.
About the Job
Experience : Required to have an experienced of 10 years in manufacturing or quality assurance tole
Need to have experience with the production, chromatography and understanding on high regulated markets
To participate in project meetings and to ensure compliance with respect to action items and project mile stones.
Candidate need to have experience with the problem solving skills and need ti have experience with the micro soft office tools.
Should have experience with the analytical skills and problem solving skills.
roles and responsibility
Need to effectively Review, approval and timely closure of Quality Management System documents (Deviations, Change controls, Out of specifications (OOS) , CAPA with risk assessments.
Able to handle and manager the Review of executed Batch records including analytical records and need to Assist in maintaining reserve sample storage.
Required for the 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.
Handling the Day to day effective monitoring and ensuring compliance of vaccine manufacturing operations with GMP and approved site procedures with excellent understanding on the process.
Thorough understanding on product linkage / inter dependencies between different quality system elements.
Timely Review of procedures, Recording sheets, Master formula records, batch manufacturing records, Protocols, Reports for Process Validation. Good understanding on simplification of complex procedures / batch records / record sheets.
Manage and handle independently prepare investigation reports and product impact assessments in line with international regulatory expectations.
Candidate is Responsible for analysis, evaluation, identification, documenting the risk and implementation of appropriate mitigation plan. Preparation of Process Risk Assessments for Vaccine Manufacturing Process using FMEA / any other risk assessment tool.
Able to manage and Perform regularly scheduled and as needed compliance walkthroughs in Production areas.
Should manage and Provide Quality oversight during In-process Sampling, Validations, Cleaning Verifications, Process activities, etc.
Needed to Ensure implementation of CAPA and its effectiveness review.
Able to Review of Aseptic Process Simulation (APS) Protocols & Reports.
Ensure and able to perform the Handling and Ensuring the readiness for Regulatory inspections and internal audits (Self inspections).
Effectively ensure the product compliance with registered dossier.
Required to involve in FMEA, Failure Investigations, Out of specifications, Root cause analysis (well versed with RCA tools), environmental monitoring and water excursions with knowledge on different work flows in e-tools (e-QMS, e-doc, LIMS, SAP etc.).
Required to Report directly to key personnel any issue beyond control and send accurate information.
Needed to collaborate with cross functions to support company objectives.