Manager QMS-Quality Assurance (Peptide API)@Raks Pharma,Dahej

Raks Pharma Pvt Ltd (Dahej) A div. of Amneal Pharmaceuticals; Dahej; Sur place; INR 900 000 - 1 300 000; Plein temps

Résumé du poste

Raks Pharma Pvt Ltd (Dahej) A div. of Amneal Pharmaceuticals in Dahej, India, seeks a senior API Quality Assurance professional to lead quality governance and regulatory readiness.

Responsibilities include change and deviation management, CAPA effectiveness monitoring, investigations of non-conforming product and customer complaints, and supporting DMF filings with robust documentation and SOP oversight.

Qualifications

• Experience in API quality assurance with leadership in USFDA/EU-approved facility.
• Leading CAPA, deviation handling and regulatory document control.
• Investigations of non-conformities, customer complaints, recalls, and returns.

Responsabilités

• Evaluate and monitor Change Management including CAPA and customer notification per SOP.
• Evaluate and monitor deviation management with impact assessment and CAPA.
• Investigate non-conforming product, deviations, complaints, recalls, and returns.
• Manage documents: SOPs, specifications, STP, protocols, formats, etc.
• Implement e-log system.
• Prepare and review SOPs and related documents.
• Monitor CAPA effectiveness.
• Provide documentary support to regulatory affairs for DMF filings.

Connaissances

Quality Assurance Leadership

CAPA investigations

Regulatory compliance

Change management oversight

Formation

M.Sc. Chemistry / B.Pharm / M.Pharm or equivalent

Description du poste

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.