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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