Sr. Officer / Executive - Production

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)