Manager – Sterile Micro / EM Compliance

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 the microbiology laboratory.

Participate in the sterile quality management review periodically

Ensure the microbial monitoring program in the site is adequate

Environmental Monitoring (EM)

Personnel Monitoring

Media Fill Simulations (Process Simulations)

Periodic review and routine check of classified areas in microbiology lab areas

Review validation / protocol studies which has potential to directly or indirectly impact the sterility of the product

Participate in the media fill program and provide meaningful insights from a microbiology perspective

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.

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 microbial testing and environment monitoring

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

Ensure appropriate Data Integrity controls are applied and followed