ProductionEngineeringQAQC

Job Description:

We are seeking an experienced Injectable Production Supervisor for our facility in Daman. The ideal candidate will have a strong background in aseptic filling QMS and plant maintenance with expertise in QA IPQA QC and microbiology.

1. Production – Aseptic Filling (Injectable)
Experience: 4–8 Years
Qualification: / / /
Key Responsibilities:

Operate and supervise aseptic filling operations for vials/ampoules in sterile environment.
Ensure compliance with cGMP SOP and regulatory guidelines.
Handling of filling stoppering capping and sealing machines.
Monitor environmental conditions in aseptic area.

Coordination with QA for line clearance and batch release activities.
Documentation of BMR BPR logbooks deviation records.
Ensure proper gowning practices and contamination control.
Troubleshoot equipment and process related issues.
Maintain productivity with focus on quality and sterility assurance.

2. QA – IPQA (In-Process Quality Assurance)
Experience: 4–8 Years
Qualification: / /
Key Responsibilities:
Perform in-process checks during manufacturing activities.
Line clearance for aseptic filling compounding filtration and packing.
Review BMR/BPR logbooks and batch related documents.
Monitor compliance with GMP GDP SOP requirements.
Handle deviation change control CAPA documentation.
Ensure data integrity compliance.
Monitor critical parameters during production process.
Participate in internal audits and regulatory inspections.
Provide guidance to production team on quality requirements.

3. QC – Microbiology
Experience: 4–8 Years
Qualification: (Microbiology / Biotechnology)
Key Responsibilities:
Perform microbiological testing of raw materials finished products and water samples.
Conduct environmental monitoring (air surface personnel monitoring).
Perform sterility testing endotoxin testing MLT.
Preparation and handling of culture media.
Maintain aseptic conditions in microbiology lab.
Documentation of test results and analytical reports.
Calibration and maintenance of microbiology instruments.
Investigation of OOT OOS results.
Ensure compliance with GLP and regulatory requirements.

4. QMS (Quality Management System)
Experience: 4–8 Years
Qualification: / /
Key Responsibilities:
Handle deviation CAPA change control incident management.
Preparation and review of SOPs specifications protocols.
Conduct internal audits and compliance monitoring.
Maintain document control system.
Trend analysis of quality events.
Preparation for regulatory audits (USFDA MHRA WHO etc.).
Training coordination and compliance tracking.
Ensure implementation of quality improvement initiatives.

5. Engineering – Plant Maintenance (Injectable Facility)
Experience: 4–8 Years
Qualification: B.E / (Mechanical / Electrical)
Key Responsibilities:
Preventive and breakdown maintenance of injectable plant equipment.
Maintenance of HVAC AHU purified water system WFI system.
Maintenance of autoclave sterilizer filling machine lyophilizer.
Calibration coordination for instruments.
Maintain utility systems like compressed air nitrogen chilled water.
Ensure equipment compliance with GMP requirements.
Documentation of maintenance activities.
Spare parts planning and inventory control.
Support validation activities (IQ OQ PQ).