07 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