Officer / Sr. Officer - QMS

Department Icon Audit & Control
Posted: 7 months ago
0-1 years
Daman, Daman & Diu
Audit & Control
work from office
Full Time

Posted: 7 months ago
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Job Description

Deviation & CAPA Management

  • Identify, report, and investigate production deviations.
  • Coordinate with cross-functional teams to implement Corrective and Preventive Actions (CAPA).
  • Track the effectiveness and timely closure of CAPAs.

Change Control Management

Participate in the initiation, review, and implementation of change controls relevant to production processes, equipment, and documents.

Audit Readiness & Compliance

Support internal, external, and regulatory audits by ensuring production documentation and practices are compliant and audit-ready.

Implement audit recommendations relevant to production.

Skills

AuditAuditsCapaCapa ManagementChange ControlProduction DocumentationRegulatory AuditsQms

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About Company

Alkem Laboratories Limited is a leading Indian pharmaceutical company with global operations, engaged in the development, manufacturing and marketing of pharmaceutical products. The Company produces branded generics, generic drugs, active pharmaceutical ingredients (APIs) and nutraceuticals, which it markets in India and internationally. Alkem has a portfolio of more than 800 brands covering all major therapeutic segments. In fiscal 2023, Alkem recorded revenues of INR 125.48 billion (USD 1.54 billion) and is amongst the top 10 pharmaceutical companies in India. The company has a presence in over 40 international markets with the United States being its largest market. Alkem has 19 manufacturing facilities – 17 in India and 2 in the United States. It employs a team of more than 16,500 dedicated professionals worldwide.
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