06 Aug
|
Intas
|
Ahmedabad
Role & responsibilities
- Conduct and review Microbial Data Deviation (MDD) investigations.
- Robust knowledge on handling of QMS deviations, CAPA, and change controls.
- Sound knowledge on compliance of global regulatory requirements including USFDA, EU GMP, EMA, PDA, WHO, and ICH guidelines.
- Exposure of regulatory inspections and internal audits.
- Mentoring experience of team members on microbiological techniques, contamination control, aseptic practices, and regulatory standards.
- Drive continuous improvement initiatives in EM programs, contamination control strategies, and laboratory practices.
- Supervise and perform routine microbiological testing such as air, surface, personnel monitoring, utility monitoring, and cleanroom qualification.
- Hands on experience on validation activities including, UDAF qualification, HVAC qualification, cleanroom area qualification, and other utility qualification
📌 QC Micro Analyst (Ahmedabad)
🏢 Intas
📍 Ahmedabad