Director, Quality Assurance, Mumbai

4 weeks ago

mumbai, India Endo Full time

Job Description Summary

This position is responsible for managing Quality Assurance activities for Digha Location and will support global quality assurance activities.

Job Description

Key responsibilities include:
 To manage and ensure on-line cGMP compliance at Formulation and Stability division by conducting periodical assessments and trainings .
 Manage and coordinate all Quality Assurance related matters on day to day basis.
 Coordinate with Manufacturing, Engineering and Quality team and provide quality guidance for successful product/method transfers and executions. Ensure GMP trainings are imparted as per plan.
 To manage and ensure all customer related queries are responded satisfactorily and in time. Ensure successful handling of regulatory, corporate and customer audits.
 Ensure the availability of resources for the department.
 Ensure training of Quality Assurance and Manufacturing personnel.

Education: Post Graduate in Chemistry with 15+ years of working experience in QA in a reputed pharmaceutical organization.

Knowledge:

Expert knowledge in the following areas:

  • Analytical Assurance
  • cGMP
  • Documentation Assurance
  • Engineering Assurance
  • Process Assurance
  • Quality Management System
  • Safety
  • Training
  • Vendor Qualification

Skills:

  • Effective system implementation.
  • Communication & Leadership skill.
  • Inter personal relationship.
  • Proactive and planning on analytical aspects.
  • Problem solving techniques.

Commitment to Diversity, Equity, and Inclusion:

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.

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