AREAS OF RESPONSIBILITY • Handling of all the activities related to Product approval form for P2P sites.
• Coordinate with the site Quality Head for PAF related activities.
• Coordinate with Operation Team for change control verification.
• Coordinate for Joint analysis at sites during new product approval.
• Flexible to travel for sites on frequent basis for review and compliance of activities.
• Coordinate for stability study monitoring, Protocol Preparation and follow-up with labs/sites for incubation.
IDEAL CANDIDATE PROFILE • Minimum 6-7 years of experience in Quality control/Assurance with Pharma Industry.
• Experience in stability study monitoring, protocol preparation.
• Flexible to travel app. 60% of time.
• Knowledge of documents requirements for export of products, working experience in site is additional advantage.
• Knowledge of Schedule 4/Schedule M, 7QC tools, ISO 22000/FSMS requirements is additional advantage.
• B.Sc/M.Sc. Chemistry.
Interested candidates can send their updated CV on email@example.com