Head Sterile Quality Compliance

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 analyzed 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