–Shristi Sharma, Team bioXone
Sun Pharma Job vacancies for Process Engineer, candidates belonging to Biotech/ Biochem and Biology can check out all of the details on the same below:
Name of the Post: Manager Process Engineer – External Manufacturing and Supply – Biologics
Location: Mumbai, Maharashtra, India
Seniority Level: Mid-Senior level
Industry: Pharmaceuticals
Employment Type: Full-time
Job Functions: Other
Primary Objective:
The Process Engineer will support the manufacture of drug substance (API) and drug Product (fill-finish and secondary packaging) of biologics. The activities range from tech transfer, technological process studies, process validation activities, data analysis to handing change controls, deviations and troubleshooting. Writing and also reviewing of DS/DP validation-related documents and key CMC sections of regulatory dossiers (different countries) are additionally required for this position.
Major Duties/Responsibilities:
- Support the operational activities at DS & DP CMO’s, as well as testing of DS/DP throughout the value chain.
- Performs Continuous Process Improvement and Process Optimization to reduce Cost of Goods.
- Subject Matter Expert (SME) on multidisciplinary CMC teams to guarantee scientifically driven decisions made.
- Review and approve master batch records, change controls, as well as deviations, CAPA to guarantee GMP compliance and operational success.
- Preparation and review of documents such as technological reports, validation documents, deviation reports and also regulatory modules.
- Help in the development of specifications for raw materials, consumables, process intermediates and drug substances.
- In collaboration with Quality, Regulatory Affairs, Project management and analytical groups support the CMO operations to achieve on-time manufacturing.
- The applicant will communicate across the organization to ensure key stakeholders are aware of project status, potential risks as well as their required action plans.
- Various other duties as assigned.
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