Sterile Production Officer

To supervise and coordinate aseptic manufacturing activities in compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, quality standards, and safety procedures. The role ensures timely execution of sterile manufacturing operations while maintaining product quality, sterility assurance, and operational efficiency.

Key Responsibilities

Production Operations

• Supervise daily aseptic manufacturing activities including formulation, filtration, filling, capping, and sterile processing operations.
• Ensure adherence to approved Batch Manufacturing Records (BMRs), Standard Operating Procedures (SOPs), and GMP guidelines.
• Monitor production schedules and ensure timely completion of batches.
• Coordinate with Engineering, Quality Assurance, Quality Control, Warehouse, and Maintenance teams for smooth operations.
• Ensure proper line clearance before commencement and after completion of manufacturing activities.

Aseptic Process Compliance

• Maintain strict aseptic practices and contamination control measures within classified areas.
• Ensure personnel follow gowning procedures and aseptic behavior requirements.
• Monitor environmental conditions and coordinate corrective actions for deviations.
• Support media fill activities, aseptic process simulations, and process validations.
• Ensure compliance with regulatory requirements from USFDA, MHRA, EU-GMP, WHO-GMP, and other applicable agencies.

Documentation & Quality

• Review and verify batch records, logbooks, equipment records, and production documentation.
• Investigate production deviations and assist in root cause analysis and CAPA implementation.
• Ensure timely closure of deviations, change controls, and quality events.
• Participate in audits and regulatory inspections.
• Maintain data integrity and documentation compliance throughout operations.

Team Management

• Supervise and guide operators and technicians during shifts.
• Conduct training on GMP, safety practices, aseptic techniques, and SOPs.
• Monitor manpower deployment and shift allocation.
• Evaluate team performance and identify training needs.

Interested candidates can send resumes to [email removed]