AM Manufacturing

Mumbai - India

Monthly Salary: Not Disclosed

Posted on: 20 hours ago

Vacancies: 1 Vacancy

Job Summary

Third-Party Manufacturing Compliance
- Ensure GMP compliance across all third-party manufacturing (TPM / Loan License) sites.
- Monitor adherence to quality standards regulatory guidelines and internal SOPs.
CQA & R&D Interface
- Provide quality oversight for CQA activities and R&D projects including product development scale-up validation and tech transfer.
- Support clinical and product development strategies to ensure market readiness.
Vendor Development & Audits
- Lead vendor qualification development and performance evaluation.
- Coordinate periodic audits of contract manufacturing organizations (CMOs) and ensure compliance closure.
Complaint Handling & CAPA
- Ensure timely investigation of product complaints deviations OOS/OOT and market feedback.
- Prepare investigation reports and implement CAPA within defined timelines.

Third-Party Manufacturing Compliance Ensure GMP compliance across all third-party manufacturing (TPM / Loan License) sites. Monitor adherence to quality standards regulatory guidelines and internal SOPs. CQA & R&D Interface Provide quality oversight for CQA activities and R&D projects including...