Role & responsibilities

1.Evaluation and Monitoring of Change Management including change review, CAPA implementation and notification to customers on the significant changes with respect to product being supplied to customers for regularization as per SOP.

2.Evaluation and Monitoring of deviation management including impact assessment, CAPA implementation and notification to customers on the significant deviations with respect to product being supplied to customers for regularization as per SOP.

3.Investigations of non-confirming product, deviations, customer complaint, product recall, return goods.

4.Document management like SOPs, specification, STP, protocol, formats, etc.

5.e-log implementation.

6.To prepare and review of SOPs and other documents as applicable.

7.Evaluation and monitoring of CAPA and its effectiveness.





8.To provide documentary support to regulatory affairs for DMF filing.

Preferred candidate profile

- M.Sc.(Chemistry)/B. Pharma. / M.Pharm. or equivalent qualification.
- 1218 years of relevant experience in API Quality Assurance, including leadership responsibilities in a USFDA/EU-approved pharmaceutical manufacturing facility.

Key Competencies

- To maintain an effective and compliant API Quality Management System through proactive quality oversight, robust investigations, effective CAPA, controlled documentation, customer satisfaction, regulatory compliance, and continual improvement.

📌 Manager QMS-Quality Assurance (Peptide API)@Raks Pharma,Dahej
🏢 Raks PharmaDahej (A div. of Amneal Pharmaceuticals
📍 Dahej