Job Description

Core Responsibilities

Documentation:

Review, create, control, and manage SOPs, batch records, validation protocols, and site master files.

Change Control:

Implement and manage change control processes for changes impacting quality.

Deviation/Incident Management:

Investigate non-conformances, manage CAPAs (Corrective & Preventive Actions), and verify effectiveness.

Audits & Inspections:

Prepare for, host, and follow up on internal, external, and regulatory (FDA, EMA) audits.

Training:

Conduct and track QMS/GMP training for personnel.

Supplier Management:

Review quality agreements, assess vendors, and track supplier performance.

Regulatory Compliance:

Ensure adherence to cGMP, ICH guidelines, and other relevant regulations.

Product Quality:

Oversee Annual Product Quality Reviews (APQR) and product release processes.

Data & Reporting:

Trend quality data, report on KPIs, and support quality communication.
Key Objectives

Maintain product identity, purity, safety, and strength. Achieve and maintain regulatory approvals. Minimize risks and prevent product recalls. Drive continuous improvement (CI) in quality processes.
Essential Skills/Knowledge

Strong understanding of GMP, GLP, and ICH guidelines. Proficiency in QMS software and data analysis. Excellent communication, leadership, and problem-solving skills.
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Education :

B. Pharm / M . Pharm .

Experience :

3 to 6 years in a quality assurance ( QMS ) In pharmaceutical (Tablet , Capsules , Pellets, Oral Powder ) manufacturing Organization .
Job Types: Full-time, Permanent

Pay: ?17,000.00 - ?35,000.00 per month

Benefits:

Food provided Health insurance Leave encashment Provident Fund
Work Location: In person