Job Responsibilities
- Handling and troubleshooting of sterile manufacturing and filling equipment.
- Managing equipment breakdown activities, root cause analysis, and CAPA implementation.
- Preparation, review, and execution of equipment qualification documents and technical documentation.
- Monitoring preventive maintenance activities to ensure minimum equipment downtime.
- Execution and monitoring of production and engineering activities in compliance with cGMP requirements.
- Preparation and review of SOPs, protocols, reports, and other GMP documentation.
- Ensuring adherence to aseptic practices and cleanroom behavior standards.
- Independently handling and managing shopfloor activities effectively.
Eligibility Criteria
- Minimum 6 years of relevant experience in sterile pharmaceutical manufacturing facilities.
- Candidates from sterile injectable pharmaceutical facilities will be preferred.
- Immediate joiners or candidates serving short notice periods will be preferred.
Mandatory Equipment Exposure
Candidates must have hands-on experience with sterile injectable manufacturing equipment including:
- Filling Lines: B+S, Bosch, Groninger, IMA, Tofflon, Optima, Truking, Steriline, etc.
- Lyophilizers
- Autoclaves
- Manufacturing & Holding Vessels