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 audits (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.
Minimum combined ten (10) years of pharmaceutical / biotech experience in a Manufacturing or Quality role.
Previous experience on the floor in vaccine manufacturing (cell culture, virus culture, chromatography, sterile Filtration), exposure to aseptic environment / aseptic practices is mandatory.
Exposure to inspections and understanding of guidelines from highly regulated market agencies like FDA, EMEA.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers.
We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.