Posted:2 days ago|
Platform:
Work from Office
Full Time
Role & responsibilities Cell Culture & Production Support: Perform aseptic handling and maintenance of cell cultures (e.g., Vero, BHK or other cell lines) in adherent and/or suspension formats. Prepare and sterilize culture media, buffers, and reagents as per batch requirements and SOPs. Monitor and record cell growth parameters, viability, and morphology. Scale-up cell cultures for downstream processing or viral seed production. Facility & Environmental Monitoring: Conduct routine facility checks including temperature, humidity, pressure differentials, and cleanroom conditions. Coordinate and ensure compliance with environmental monitoring schedules (viable/non-viable particles, surface, and air sampling). Assist in maintaining facility readiness and hygiene per cGMP standards. Documentation & Quality Compliance: Prepare and review SOPs, batch manufacturing records (BMRs), logbooks, and calibration/maintenance records. Maintain data integrity and compliance with Good Documentation Practices (GDP). Participate in internal and external audits, ensuring timely closure of CAPAs. Quality Management System (QMS): Support implementation and maintenance of QMS elements: deviations, change controls, CAPA, risk assessments, and document control. Participate in training programs related to QMS and GMP compliance. Working knowledge of QMS software/tools is an added advantage. Desired Skills: Proficiency in aseptic techniques and cleanroom operations. Strong understanding of GMP, GLP, GDP, and ISO standards. Good written and verbal communication skills. Job Location: Kadi, Gujarat ( Bus facility available from Ahmedabad, Kalol & Kadi)
Hester
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