Executive / Sr. Executive – Quality Assurance & Compliance

Aioniospharma; Bengaluru; On-site; INR 400,000 - 1,000,000; Full time

Job summary

Aioniospharma in Bengaluru is seeking a quality assurance professional to ensure all marketed pharmaceutical products meet regulatory and compliance standards. The role emphasizes vendor compliance, documentation control, and product quality monitoring.

The ideal candidate will have a B.Pharm or M.Pharm degree and 2–6 years of relevant experience in QA/QC or regulatory roles within pharma. Strong vendor management skills and understanding of regulatory frameworks are essential.

Qualifications

• Minimum of 2 years experience in QA/QC/Regulatory within pharma marketing.
• Strong understanding of WHO-GMP / Schedule M and DCGI regulations.
• Good coordination and vendor management skills.

Responsibilities

• Evaluate and approve third-party manufacturers and suppliers.
• Review and approve certificates of analysis and regulatory documents.
• Handle product complaints and maintain registers.

Skills

Vendor management

Regulatory compliance

Quality Assurance

Documentation control

Education

B.Pharm / M.Pharm / Life Sciences

Job description

This role focuses on ensuring all marketed pharmaceutical products meet regulatory, quality, and compliance standards. Since there is no manufacturing setup, the emphasis is on vendor compliance, documentation control, product quality monitoring, and market feedback handling.

Vendor & Third-Party Compliance

• Evaluate and approve third-party manufacturers, packers, and suppliers.
• Ensure all vendors comply with WHO-GMP / Schedule M requirements.
• Coordinate for vendor audits and maintain audit reports and CAPA tracking.

Product Quality Assurance

• Review and approve COA (Certificate of Analysis), BMR/BPR (where applicable), and release documents from manufacturers.
• Ensure products released to market meet defined specifications.
• Monitor batch traceability and documentation.

Regulatory & Documentation Control

• Maintain product dossiers, technical documents, and regulatory files.
• Ensure label claims, packaging materials, and promotional inputs comply with DCGI/FSSAI guidelines (as applicable).
• Control and update SOPs, quality manuals, and policies.

Market Complaints & Pharmacovigilance Support

• Handle product complaints from the field.
• Coordinate with manufacturers for investigation and closure reports.
• Maintain complaint registers and trend analysis.
• Support adverse event reporting (if applicable).

Distribution & Supply Chain Quality

• Ensure proper storage and distribution practices (GDP compliance).
• Monitor temperature-sensitive product handling.
• Conduct checks on C&F agents and stockists.

Internal Compliance & Training

• Conduct internal audits across departments.
• Train sales and marketing teams on compliance, product handling, and ethical promotion practices.
• Ensure adherence to company SOPs and industry standards.

Artwork & Promotional Material Review

• Review product labels, visual aids, and marketing materials for compliance with regulatory norms.
• Ensure no misleading claims are used.

Qualifications

• Qualification: B.Pharm / M.Pharm / Life Sciences
• Experience: 2–6 years in QA/QC/Regulatory in pharma marketing or third-party manufacturing setup
• Strong understanding of:
  • WHO-GMP / Schedule M
  • DCGI regulations
  • Documentation and audit processes
• Good coordination and vendor management skills