Quality Executive - Trade Generics

Job Title: Quality Executive - Trade Generics

Locations: Mumbai & Surat

Key Responsibilities

1. 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 Skills

• Experience:

  • 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 Apply

Interested candidates can email their updated resumes to ruchika.a@beyondthecv.com.