Vendor Qualification - CQA

2 - 7 years

3 - 8 Lacs

Posted:1 month ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

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About Us:

Unison Pharmaceuticals is a leading organization in the pharmaceutical industry, committed to providing high-quality healthcare products. We are seeking a highly motivated and experienced professional to join our team as Executive/Sr. Executive/Assistant Manager in the Vendor Qualification team in the CQA (Corporate Quality Assurance) department.

Key Responsibilities:

  • Conduct Nitrosamine and Elemental Impurity Assessment for API & Finished Products.
  • Perform periodic evaluation and audits of vendors (API, intermediates, excipients).
  • Review and assess DMFs (Drug Master Files) and prepare regulatory responses.
  • Prepare Quality Risk Management (QRM) reports for excipients, including audit reports, compliance reviews, and closure.
  • Track and manage Quality Technical Agreements (QTA) and ensure timely updates.
  • Handle vendor change notifications and ensure smooth transitions.
  • Prepare equivalency reports for raw materials (RM) and track licenses/certification expiry for RM/PM.
  • Develop and maintain the audit schedule for internal and external audits.

Qualifications:

  • Bachelor's or Master's degree in Pharmacy, Chemistry, or a related field.
  • 3-12 years of experience in CQA within the pharmaceutical industry.
  • In-depth knowledge of regulatory guidelines and quality assurance processes.
  • Strong analytical skills with attention to detail.
  • Excellent communication and vendor management skills.

What We Offer:

  • Competitive salary and benefits package.
  • A dynamic and collaborative work environment.
  • Opportunities for professional growth and development.

How to Apply:

Join us in our mission to ensure quality and compliance at every step of the pharmaceutical development process!

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Unison Pharmaceuticals logo
Unison Pharmaceuticals

Pharmaceuticals

Chicago

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