Vendor Qualification - CQA

Unison Pharmaceuticals; Ahmedabad District; On-site; INR 800,000 - 1,200,000; Full time

Benefits offered by this job

Competitive salary

Growth opportunities

Collaborative environment

Job summary

Unison Pharmaceuticals, located in Prahladnagar, seeks an Executive/Sr. Executive in the Vendor Qualification team within CQA. This role involves Nitrosamine and Elemental Impurity assessments, vendor audits, DMF reviews, and QRM documentation.

The candidate should have 3–12 years of CQA experience in pharma, with strong regulatory knowledge, analytical skills, and excellent vendor management capabilities. Growth in a dynamic environment is offered.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Chemistry, or related field.
• 3-12 years of experience in CQA within pharmaceutical industry.
• In-depth knowledge of regulatory guidelines and quality assurance processes.

Responsibilities

• Conduct nitrosamine and elemental impurity assessments for API and finished products.
• Perform periodic vendor evaluations and audits (API, intermediates, excipients).
• Review and assess DMFs and prepare regulatory responses.
• Prepare QRM reports for excipients, including audit reports and compliance reviews.
• Track and manage QTA and ensure timely updates.
• Handle vendor change notifications and ensure smooth transitions.
• Prepare equivalency reports for RM and track licenses/certification expiry.
• Develop and maintain the audit schedule for internal and external audits.

Skills

Analytical skills

Vendor management

Regulatory knowledge

Communication

Education

Bachelor's/Master's in Pharmacy or Chemistry

Job description

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.

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