Job Description

About the job

Job Purpose

To execute and monitor sterile pharmaceutical manufacturing activities in compliance with approved procedures, GMP requirements, safety standards, and production plans, ensuring product quality, sterility, and timely output.

Key Roles & Responsibilities

• Execute sterile production activities according to approved SOPs, Batch Manufacturing Records (BMRs), and GMP requirements.
• Perform and monitor manufacturing processes including aseptic processing, filling, preparation, and related sterile operations as applicable.
• Ensure proper line clearance, equipment readiness, area cleanliness, and material availability before production activities.
• Monitor critical process parameters and promptly report any deviation, abnormality, or process discrepancy.
• Ensure accurate and timely completion of batch documentation and production records.
• Follow aseptic techniques, gowning procedures, and contamination-control requirements.
• Coordinate with QA, QC, Engineering/Maintenance, and Warehouse to resolve production issues and maintain workflow.
• Support investigations related to deviations, non-conformities, and production incidents.
• Ensure proper handling, identification, and reconciliation of materials and finished/intermediate products.
• Maintain production equipment and workplace according to applicable safety, hygiene, and GMP standards.
• Participate in process improvement, CAPA, validation/qualification activities, and GMP inspections/audits when required.
• Support training and coaching of production technicians/operators on relevant procedures and GMP practices.

Education

• Bachelor’s degree in pharmacy from a recognized university.
• Professional registration/licensing as applicable.

Experience & Requirements

• 1–3 years of experience in pharmaceutical manufacturing, preferably in sterile production/aseptic processing.
• Good knowledge of GMP, GDP, aseptic techniques, contamination control, and pharmaceutical manufacturing practices.
• Familiarity with sterile manufacturing equipment and processes is preferred.
• Good documentation and record-keeping skills.
• Good analytical, problem-solving, and communication skills.