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Position: Manager – Corporate Quality Assurance Manager

Location: Kurla, Mumbai, Maharashtra, India

Job Description:

  • Responsible for driving continual improvement initiatives at all sites.
  • Supporting sites for being ready for audits and inspections. Face inspections for corporate-related responsibilities.
  • Ensure that Quality systems are in sync with current regulations by sharing updated regulatory guidance to all PEL sites and provide training to sites on new regulations.
  • Updating sites about warning letters and ensure compliance against each observation across PEL sites. Provide guidance to sites on mapping and implementing CAPAs.
  • Handling projects which are strategic in nature such as QUEST, 24/7 Audit Readiness at sites, Data integrity Compliance, etc.
  • Reviewing  sites data on process capability, OEE, Critical complaints, deviations, etc
  • Preparing and updating of Corporate Guidelines in lines with new regulations
  • Conduct audits at domestic and international sites.
  • Conduct monthly reviews with all sites. Coordinate and consolidate data for Management reviews.

Desires Skills & Knowledge

  • Should have worked in Corporate quality and should be well versed with roles and responsibilities of Corporate Quality Function. Should be well versed with requirements of management reviews.
  • Should be able to effectively consolidate and present site data to management using powerful presentation skills.
  • Sound knowledge of GMP regulations and guidelines (USFDA, EU, WHO, etc).
  • Good communication skills (Verbal & written).
  • Adequate experience in handling data integrity audits. Aware of DI requirements and recent trends and expectations of regulators
  • Experience Conduct of Site audits .
  • Risk Management and Investigation handling expertise
  • Should be aware of Regulations of formulation and API. Sterile experience would be preferred.

Qualification: B.Pharma/M.Pharma/M.Sc

Experience: 12 -15 years on industry experience in a GMP environment.

Salary: Negotiable

Contact Details:

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