Vendor Qualification - CQA

Location: Unison Pharmaceuticals, Prahladnagar

Experience: 3-12 years

Designation : Executive/Sr. Executive

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:
Please send your resume and a cover letter to [[email protected]] with the subject line "Application for the role of Vendor Qualification in Unison Pharmaceuticals"

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