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Hester
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Executive / Senior Executive - Production

Executive / Senior Executive - Production

Hester

5 - 6 years

4 - 5 Lacs

Kadi Ahmedabad

Posted:2 months ago| Platform:

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Skills Required

Capa Scale Up Qms System Cell Culture Batch Manufacturing Bmr culture media

Work Mode

Work from Office

Job Type

Full Time

Job Description

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:

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