Quality Assurance (Qualification)

Quality Assurance (Qualification)

work outline icon5 - 7 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

Mangalam Drugs & Organics Ltd

time outline iconVapi, Gujarat, India

Posted on 27-12-2024

41 Views

1 Vacancy

Description

  • Lead and perform the qualification of equipment, instruments, systems, and facilities as per regulatory requirements and internal SOPs.
  • Ensure that equipment and systems are appropriately qualified, including Installation Qualification , Operational Qualification , and Performance Qualification (PQ).
  • Coordinate and oversee qualification activities across different departments, including production, R&D, and maintenance.
  • Prepare and maintain qualification protocols, reports, and records, ensuring they are compliant with cGMP, regulatory guidelines and company standards.
  • Review and approve qualification documents and ensure they meet compliance requirements and are completed in a timely manner.
  • Maintain accurate records of all qualification activities for audit purposes and regulatory inspections.
  • Stay up-to-date with the latest regulatory changes and qualification standards to ensure compliance.
  • Prepare for and assist in internal and external audits by providing qualification documents and supporting data.

Category

Pharmaceuticals

Functional Area

Pharma Quality Assurance (QA)

Preferred Education

BSc ChemistryMSc Chemistry

Key Skills

Attention to DetailProblem solvingDecision-MakingTeam WorkPositive Attitude

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