Officer/Senior Officer/Executive

Intas

2 - 7 years

1 - 6 Lacs

Ahmedabad

Posted:6 hours ago| Platform:

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Skills Required

Injectables Autoclave Parenteral Aseptic Sterile Filling Lyophilization Injection Vial Washing Small volume parenteral Batch Manufacturing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Supervise sterile manufacturing processes such as compounding, filtration, filling, and sealing of injectable products.
Ensure compliance with cGMP, FDA, and other regulatory requirements in all production activities.
Monitor and control environmental conditions in aseptic areas, ensuring cleanroom discipline is maintained.
Coordinate with quality control, quality assurance, and engineering departments for production-related activities.
Review and maintain batch manufacturing records (BMR), logbooks, and other relevant documentation.
Perform in-process checks and ensure timely reporting of deviations and non-conformances.
Assist in validation activities including media fill, equipment qualification, and process validation.
Train and guide production staff on aseptic techniques, gowning procedures, and SOP adherence.
Ensure timely availability of materials, equipment, and manpower for smooth production operations.
Participate in internal and external audits and support compliance initiatives.

Preferred candidate profile

Education: B.Pharmacy/ M.Sc.
Experience: 1-7 years in injectable (sterile) production in a pharmaceutical company.

Knowledge of aseptic processing and cleanroom protocols.
Familiarity with equipment like autoclaves, vial washers, filling lines, lyophilizers, and isolators.
Understanding of documentation and regulatory requirements (e.g., USFDA, EU GMP, WHO GMP).

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