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Senior Executive/ Assistant Manager- Upstream & Downstream

Senior Executive/ Assistant Manager- Upstream & Downstream

Enzene Biosciences Ltd

0 years

0 Lacs

Chakan Maharashtra India

Posted:1 month ago| Platform:

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Skills Required

manufacturing chromatography compliance support management controls risk qc engineering audits commissioning sap

Work Mode

On-site

Job Type

Full Time

Job Description

Hands-on execution of biopharmaceutical manufacturing processes in upstream (single-use bioreactors, media preparation systems, single-use systems) and downstream (AKTA systems, chromatography columns, UF/DF systems, buffer preparation units, virus filtration, single-use technologies).
Conduct batch operations in compliance with cGMP guidelines, ensuring adherence to quality standards and regulatory requirements.
Maintain and support Quality Management Systems activities including deviations, change controls, risk assessments, and CAPA implementation.
Ensure compliance with Environmental Health & Safety (EHS) protocols during manufacturing operations.
Collaborate effectively with cross-functional teams including QA, QC, validation, engineering, and supply chain to support smooth batch execution and issue resolution.
Participate in internal and external audits, and support equipment commissioning and qualification, computer system validation (CSV), and SAP-based documentation.

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