Job Description

Job Title: Quality Executive - Trade GenericsLocations: Mumbai & SuratKey Responsibilities1. Manage Quality Assurance and Control

• Ensure all products meet the highest quality, safety, and regulatory compliance standards for the new Trade Generics business.
• Collaborate closely with senior advisors and the procurement manager for QA/QC of contract manufacturers and final products.

2. Inspection and Audit of Contract Manufacturers

• Provide quality oversight to ensure selected CDMOs comply with GMP, ISO, and pharmaceutical regulatory standards.
• Conduct regular audits to ensure thorough batch reviews and quality control throughout the production process.

3. Product Quality Assurance

• On-site: Conduct detailed QC and batch reviews at the CDMO manufacturing site.
• Off-site: Review product quality upon receipt at the warehouse.

4. Regulatory Compliance and Documentation

• Drive regulatory compliance for product and process quality while liaising with relevant regulatory bodies.
• Maintain thorough documentation to support regulatory submissions and inspections.

Experience and SkillsExperience:

• Minimum 5 years of experience in QA/QC roles in the pharmaceutical industry.
• Strong knowledge of regulatory standards is essential.
• Experience leading audits, inspections, and ensuring regulatory compliance with contract manufacturers is preferred.

Relevant Roles:

• Quality Manager or Quality Executive at a pharmaceutical company.

Skills:

• In-depth knowledge of GMP, ISO standards, and pharmaceutical regulatory guidelines.
• Excellent auditing and documentation skills.
• Strong attention to detail and problem-solving abilities.

Role Reporting

• Initially reports to the Promoter.
• Will later report to the Operations & Supply Chain Head.

Qualifications

• Bachelors degree in a relevant field.

Additional Information

• Opportunity to contribute to a new Trade Generics business.
• Collaborate on QA/QC initiatives for CDMOs and final products.
• Competitive compensation and growth opportunities.

How to ApplyInterested candidates can email their updated resumes to .

Beyond The CV