Job Description
- Responsible for management of Microbiology lab.
- Responsible for allocation of work in Microbiology lab.
- To monitor sample management system and planning of testing and release of raw material, in-process samples, validation samples, packing material and finished product from microbiology laboratory as per defined procedure.
- Responsible for ensuring the testing and release of raw material, packing material and finished product as per agreed timelines.
- Responsible for reviewing and approving the documents related to microbiological testing.
- Responsible for managing Environmental monitoring, Utility monitoring (water/Compressed gases) program.
- Inform to QC Head/Designee and Responsible for Reporting of OOS, OOT, Incident, deviation, CAPA and change control as per procedure.
- Responsible for leading, investigating and closure of Microbiology Out of Specification Results and finalization of associated CAPA.
- Responsible for reviewing of Standard Operating Procedures, imparting training on new/changed procedures and assuring implementation of the same in Microbiology lab.
- Responsible for preparation of qualification/validation protocols, ensuring validations/qualifications are executed appropriately as per the procedures and reviewing/approving the validation/qualification reports.
- Responsible for planning and management of Microbiology related activities during Aseptic Process Simulation.
- Responsible for participation in activities related to Sterility Assurance of product/process.
- To impart training to subordinates on aseptic techniques / behaviours and sterility assurance elements.
- To lead regulatory/customer audits wrt Microbiology operations and ensure that any actions generated for Microbiology are completed as per agreed timelines.
- Responsible for enhancing overall compliance in Microbiology lab as per current regulatory expectations.
- To perform any other work assigned by the head of the department based on need of organization.
- To follow good documentation practices.
- To adhere the cGMP standards.
- To adhere to the organization rules and regulation.
- To ensure and assist the Head Sterile Quality Compliance for driving excellence in sterility assurance practices, meeting the global regulatory requirements, drive sterility Assurance Program at site.
- To execute the sterile quality management review periodically.
- Periodic review and routine check of classified areas like manufacturing, Microbiology and utility areas.
- Preparation & adherence to Sterility Assurance Calendar consisting of Review timelines, training calendar and requalification.
- Ensuring SOP adherence to clean room facility / utilities/ equipment / personnel qualifications whichever has a potential to impact the Sterility of the product.
- Review validation / protocol studies which has potential to directly or indirectly impact the sterility of the product.
- Oversee the media fill program.
- Oversee the microbial OOS and OOT investigations, ensure microbial excursions are adequately handled and investigated.
- Ensure microbial trend data is analysed and actions are taken proactively.
- Review change controls related to Facility/ Process/ Utilities which may impact the current validated state with a focus on Sterility.
- Ensuring periodic training of personnel involved in Sterility process and ensure practices to be followed while ensuring desired behaviour on shop floor.
- Oversight of aseptic interventions, gowning qualifications, and contamination control strategies.
- Ensure appropriate Data Integrity controls are applied and followed.
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