At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
Key responsibilities:
- Planning and monitoring of environmental monitoring within facility.
- Evaluation and interpretation of environmental monitoring VPC, NVPC and utility monitoring (nitrogen gas, compressed air, CO2 gas) results.
- Oversight of the aseptic operations, environmental monitoring activity – for viable particle count (VPC) and Non-Viable particle count (NVPC).
- To review trend for viable and non-viable monitoring data and suggest action if any.
- To review trend of microbiological monitoring of personnel of aseptic area. To participate in the aseptic process risk assessment.
- To participate in evaluating the sampling locations for environmental monitoring based on risk assessment and critical interventions.
- Planning and monitoring to maintain all environmental monitoring related all systems.
- To review smoke study protocol and executed videos.
- Handling of Environmental monitoring (Viable and non-viable) related incident.
- To review the incident related to aseptic practices.
- Participate in the microbiological related incidents, investigation and other microbial impact assessment wherever and whenever required.
- Planning and monitoring to media fill related activities
- Handling of media fill visual inspection activity and media fill video review and summary preparation.
- To participate in media fill process. Evaluate the protocol for interventions to be performed and review of media fill related documentation.
- To monitor clean room practices during routine production and media fill runs to evaluate and to suggest improvement in practices if required.
- Participate in the investigations media fill investigations.
- Responsible for the Aseptic core monitoring evaluation and compilation of sterility assurance review board data.
- Conducting the sterility assurance review board and implementing the actions are derived from sterility assurance review board.
- Involve implementation of contamination control strategy (CCS) across all the blocks and CCS assessment report review.
- ACT as system owner and ensure computerized system are validated for its intended use through its lifecycle.
- Ensure the computerized systems validated in compliance with the quality policies, standards and procedures and are maintained in validated statue throughout the lifecycle.
- Planning and monitoring for training of the analysts and newly joined employee
- Planning and monitoring for pharmacopeia changes updating
- Planning and monitoring for preparation and reviewing of documents
- CAPEX approval and annual budgeting
- Timely response to audit compliance.
- To fulfil the regulatory requirements.
- Support the assessment and remediation of identified activities as part of various corporate initiatives.
