Assistant Manager / Senior Executive - Contract Quality Assurance (CQA) for Third-Party Manufacturers

Position Summary

The Assistant Manager or Senior Executive in External Quality is tasked with managing and ensuring compliance of quality practices within third-party contract manufacturing organizations (CMOs). This role is pivotal in maintaining GMP adherence and product quality while facilitating seamless collaboration between internal stakeholders and external partners.

Key Responsibilities

• Supervise quality assurance activities at contract manufacturing locations within the designated region.
• Serve as the regional quality liaison addressing compliance and quality concerns.
• Conduct inspections on finished goods, review batch documentation, and approve batch releases.
• Analyze finished product data to assist in launching new products from third-party manufacturers.
• Ensure in-process quality checks for various dosage forms including tablets, capsules, oral liquids, external preparations, and sterile products.
• Observe and monitor manufacturing floor operations to confirm GMP compliance.
• Implement and evaluate process validation efforts and stability studies.
• Prepare comprehensive Annual Product Quality Reviews (APQR).
• Oversee manufacturing processes and perform finished product testing firsthand.
• Carry out quality audits of contract manufacturers and monitor corrective action progress.
• Manage relationships and ensure coordination with contract manufacturing entities.

Candidate Profile

• Possesses 10 to 12 years of experience in pharmaceutical quality operations.
• Demonstrates thorough familiarity with GMP standards and regulatory inspections.
• Has practical experience with shop floor quality operations.
• Is willing to travel extensively within India and internationally as required.
• Capable of making autonomous, timely decisions in evolving environments.
• Exhibits strong interpersonal skills to effectively collaborate across functions and stakeholders.

Educational Qualifications

• Bachelor’s or Master’s degree in Pharmacy (B.Pharm or M.Pharm), or
• A Science graduate with pertinent industry experience.

Required Competencies

• Comprehensive knowledge of manufacturing processes for oral solid dosage forms and sterile products.
• Experience in managing and coordinating with contract manufacturers.
• Extensive understanding of GMP and GLP standards.
• Excellent problem-solving and decision-making capabilities.
• Strong communication and organizational skills.