Experience: At least 2 years’ experience in quality assurance or quality systems in distribution center/affiliates and/or manufacturing sites. Specific Knowledge: Experience in cGDPs, cGMPs, Quality for Marketing Affiliate. Quality Assurance and Quality control and/or manufacturing processes. SAP .

Assure compliance of GxP, regulatory and internal standards according to quality policies and applicable requirements within Insud Pharma Group.

Management of quality activities in products commercialized in different countries under Exeltis MAs. (Complaints, Deviations, PQRs, Recalls, Quality Agreements, etc). Support to the MAH to compile to the applicable local legislation where the products are marketed.

Responsibilities

• Reporting to Exeltis Manufacturing Quality Manager.
• Ensuring that appropriate Quality systems are established, implemented, and maintained in each market, and appropriate oversight is in place to ensu...