Manager / Senior Manager - Quality Assurance

Role: Manager / Senior Manager - Quality Assurance

Job Location: Aurangabad (Chattrapati Sambhajinagar)

At VIATRIS,

• 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.