Manager / Senior Manager - Quality Assurance

2 weeks ago

Aurangabad, India VIATRIS Full time

Role: Manager / Senior Manager - Quality Assurance

Job Location: Aurangabad (Chattrapati Sambhajinagar)

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via:

  • Access Providing high quality trusted medicines regardless of geography or circumstance;
  • Leadership Advancing sustainable operations and innovative solutions to improve patient health; and
  • Partnership Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here's how this role, will make an impact:

Role & responsibilities

  • Responsible for overall Management of specification and standard test procedure which includes preparation, review and approval at site.
  • Review and Approval of Specification and Standard Test Procedure of Raw material / Finished products.
  • Review and Approve Method Transfer /validation and verification analytical reports and Protocols.
  • To coordinate for analytical method transfer/validation and verification from other locations and ensure the readiness of specification and standard Test procedure.
  • To approve or reject the Certificate of analysis for Quality Control Release.
  • Review of the change controls.
  • Implementation and tracking of Pharmacopeial changes in specification and standard test procedure.
  • Implementation and tracking of CEP and DMF notification of API.
  • Support for Analytical documents required for regulatory submission.
  • To approve the stability study data in LIMS.
  • To review and approve working standard and Impurity Standard Qualification Protocols & Reports.

Qualification & Experience

  • Candidate must be B. Pharm/ M. Pharma/ M. Sc In Chemistry
  • Experience- Candidate must have 12+ years experience in reputed pharma Organizations.
  • Candidates must be willing to work in shifts
  • Candidate who have faced regulatory Audits like FDA & MHRA Audit will be preferred.

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