Head Sterile Quality Compliance

Role & responsibilities

- Responsible for driving excellence in sterility assurance practices, meeting the global regulatory requirements, drive sterility Assurance Program at site

- Conduct 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.

- Environmental Monitoring (EM)

- Personnel Monitoring

- Media Fill Simulations (Process Simulations)

- 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 behavior on shop floor

- Ensure the microbial testing at the laboratory meets the appropriate guidance and pharmacopeia

- Ensure the microbial data generated in laboratory is used meaningfully for plant operations

- Oversight of aseptic interventions, gowning qualifications, and contamination control strategies

Ensure appropriate Data Integrity controls are applied and followed

Preferred candidate profile