summary

job details

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.

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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.

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