What are the responsibilities and job description for the Manager 1 - Microbiology position at Sun Pharmaceutical Industries, Inc.?
Company : Sun Pharmaceutical Industries Ltd
If you want to know about the requirements for this role, read on for all the relevant information.
Education : M. Sc. (Microbiology)
Experience : 12 Years
Responsibilities :
- Authorize to sign (as a doer & reviewer) :
- Parenteral GMP documents
- Aseptic area monitoring data
- Participate in the aseptic process risk assessment.
- Evaluate sampling locations for environmental monitoring based on risk assessment and critical interventions.
- Evaluate and perform risk assessment of airflow and air classification based on aseptic processes involved like filling, filtration, lyophilization, and capping.Qualification and Validation :
- Review qualification protocol and reference related to area qualification.
- Review smoke study protocol and executed videos.Media Fill :
- Participate in media fill process. Evaluate the protocol for interventions and review media fill-related documentation.
- Monitor aseptic practices during routine production and media fill runs, suggesting improvements if required.Monitoring :
- Oversight of aseptic operations and environmental monitoring activities – for viable particle count (VPC) and non-viable particle count (NVPC).
- Sampling, testing, evaluation, and interpretation of environmental monitoring results (VPC, NVPC, PEP, and utility monitoring results).
- Review trends for viable and non-viable monitoring data and suggest actions if necessary.
- Review trends of microbiological monitoring of personnel in the aseptic area.
- Train personnel entering the aseptic area; qualify and disqualify personnel for aseptic area entry.
- Review incidents related to aseptic practices.
- Participate in microbiological-related incidents, investigations, and microbial impact assessments as required.Communication between QA and Microbiologist :
- Review observations given by QA related to aseptic area and sterility assurance, performing necessary impact assessments.
- Inform QA and production of any environmental monitoring incidents.Training :
- Impart training on continual improvement in aseptic processes and sterility assurance as per global CAPA provided by Corporate Quality (e.g., PDA, USFDA, Warning letters related to aseptic practices and sterility assurance, EU Guidelines, and others).Documentation :
- Document activities according to defined SOP.
- Prepare SOPs and ensure timely revisions as required.
- Prepare and execute study protocols.
- Any other responsibilities assigned from time to time orally or in writing by the Department Head.
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