09 Aug
|
Naukri Assist
|
Mumbai
09 Aug
Naukri Assist
Mumbai
Role & responsibilities
This person is a Corporate Sterility Assurance expert who ensures that all sterile manufacturing plants follow the same high standards and regulatory expectations.
Instead of working in one manufacturing plant, they support multiple sterile manufacturing sites by:
- Setting corporate sterility standards and SOPs
- Reviewing qualification and validation strategies
- Supporting investigations related to sterility failures
- Reviewing CAPAs and Change Controls
- Supporting regulatory inspections (USFDA, MHRA, EU GMP, etc.)
- Reviewing recent sterile facility designs
- Driving CQV (Commissioning, Qualification & Validation)
- Mentoring site teams on sterility assurance
- Making sure all sterile plants are inspection-ready
In short: Corporate expert who defines, reviews and improves sterility assurance systems across multiple sterile manufacturing sites.
📌 CQA Corporate Quality- sterile operations, qualifications & validation (Mumbai)
🏢 Naukri Assist
📍 Mumbai