Job Description

The Quality Manager position is key in fostering a culture of quality within the Company organization and acts as an ambassador for the QA department. The Quality Manager, Quality Assurance has an active role in the preparation, maintenance, and execution of the internal and vendor Strategic and Annual Audit Program as well as leading all aspects of the design, implementation and management of internal and vendor audits and corresonding quality risk management activities. Core responsibilities of the Quality Manager are

- Audit Universe
- Develops and maintains the internal Quality Risk Assessment methodology.
- Develops and maintains a comprehensive Audit Universe.
- Leads Quality Assurance activities in relation to procurement and vendor oversight.
- Develops, maintains, and manages mechanisms that assure ongoing monitoring and compliance with all applicable laws and regulations including but not limited to EU GVP, USFDA CFRs, JMPA and ICH-E6.
- Partners closely with Vendor Management and operations teams,



driving risk-based and compliant audit strategy.

- Auditing and Audit management

- Coordinates and contributes to internal system and/or vendor audits initiated by the Company, according to the Company Audit Plan, including effective management of pre-audit and post-audit activities.
- As required, and within their area of GxP expertise, conducts audits or coordinates audit documentation peer review and quality control activities.

- Other

- For Client contracted services within Quality Assurance area, undertakes activities in relation to the Quality as a Service, such as planning, coordinating or conducting audits, and providing GxP QA consultantcy in line with their expertise and experience.
- Monitors compliance within the organization to ensure early identification and review its impact on audit strategy, audit plans and its execution.

📌 Quality Manager, Quality Assurance (Pune)
🏢 Ergomed
📍 Pune