Officer To Executive-IPQA- Quality Assurance-Peptide API @ Raks, Dahej

Raks Pharma Pvt Ltd (Dahej ) - A div. of Amneal Pharmaceuticals; Dahej; On-site; INR 600,000 - 900,000; Full time

Job summary

Raks Pharma Pvt Ltd (Dahej) – a division of Amneal Pharmaceuticals – is seeking a qualified API Quality Assurance professional to monitor production operations, enforce cGMP documentation, and ensure release of API batches. The role emphasizes strict compliance, line clearance, and robust data integrity.

The candidate will review BMR/BPR/ECR, manage sampling records, and oversee documentation controls across finished products, labels, seals, and dispatch processes, contributing to regulatory

Qualifications

• M.Sc.(Chemistry)/B. Pharma./M.Pharm. or equivalent qualification.
• 0407 years of relevant experience in API Quality Assurance in a USFDA/EU-approved pharmaceutical manufacturing facility.

Responsibilities

• To take plant round for online monitoring of production operations.
• To issue and control of documents like SOP, BMR, BPR, BCR, forms, logbooks, protocol etc.
• To Issue and control of finished product label/product container seals /sealing of the containers at time of sampling and dispatch.
• To review dispatch of finished product and maintain record for the same.
• To review BMR, BCR, BPR, ECR and analysis records before release of API.
• To perform sampling of APIs, maintain its records and ensure the cleaning of sampling tools.
• To perform swab and rinse sampling after equipment cleaning as when needed.
• To provide line clearance at the time of product changes over.
• To monitor/Maintain/Review of Records and Handling of controlled/Retained samples of Intermediates/Finished API/KSM.

Education

M.Sc.(Chemistry)/B. Pharma./M.Pharm. or equivalent qualification

Job description

Role & responsibilities

1.To take plant round for online monitoring of production operations.

2.To issue and control of documents like SOP, BMR, BPR, BCR, forms, logbooks, protocol etc.

3.To Issue and control of finished product label/product container seals /sealing of the containers at time of sampling and dispatch.

4.To review dispatch of finished product and maintain record for the same.

5.To review BMR, BCR, BPR, ECR and analysis records before release of API.

6.To perform sampling of APIs, maintain its records and ensure the cleaning of sampling tools.

7.To perform swab and rinse sampling after equipment cleaning as when needed.

8.To provide line clearance at the time of product changes over.

9.To monitor/Maintain/Review of Records and Handling of controlled/Retained samples of Intermediates/Finished API/KSM.

Preferred candidate profile

• M.Sc.(Chemistry)/B. Pharma. / M.Pharm. or equivalent qualification.


• 0407 years of relevant experience in API Quality Assurance in a USFDA/EU-approved pharmaceutical manufacturing facility.

Key Competencies

• Strong knowledge of cGMP, GMP documentation, batch record review, API sampling, line clearance, finished product control, data integrity, regulatory compliance, and effective coordination.

• 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.