QA/QC job vacancy at Bangalore in Aionios Pharma

Key Responsibilities

1. 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.

2. 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.

3. 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.

4. 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).

5. 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.

6. 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.

7. Artwork & Promotional Material Review

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