Job Description

Quality Systems & Compliance:

Maintain and monitor the implementation of cGMP, GDP, and GLP standards across departments. Assist in the development and maintenance of SOPs, quality manuals, and quality policies. Ensure compliance with national and international regulatory requirements (e.g., USFDA, EU, WHO, MHRA, etc.).

Documentation:

Review and approve batch manufacturing records (BMRs) and batch packaging records (BPRs). Ensure timely closure of deviations, change controls, CAPAs, and complaints. Oversee document control and archival processes.

Audit Management:

Prepare for and participate in internal and external audits. Support the closure of audit findings with appropriate corrective and preventive actions. Maintain audit readiness of the facility.

Training:

Conduct GMP and quality training sessions for new and existing employees. Evaluate training effectiveness and maintain training records.

Product & Process Quality Oversight:

Review product quality trends and support in root cause investigations. Collaborate with production, QC, and R&D teams to ensure product quality at all stages. Monitor and review ongoing stability studies.

Continuous Improvement:

Participate in quality risk assessments and continuous improvement initiatives. Support the implementation of new quality tools and systems.
Job Type: Full-time

Pay: ?700,000.00 - ?1,500,000.00 per year

Benefits:

Health insurance Leave encashment Provident Fund
Schedule:

Day shift
Work Location: In person