QA/RA Manager Eastern Europe

You will report to the Country Manager and in doted line to the European QA/RA Director.

QA Mission:
- Implementation and maintenance of an adequate Quality System
- Implementation, maintenance and improvement of Quality documentation
- Management of self assessment and of the audits of Notified Body, as wells as inspections by Health Authorities
- Management of the customer complaints, recall and withdrawal, the deviations and the CAPAS
- Management of the quality aspects in the development, sourcing and supply of non-group products
- Development and improvement of the Quality management through all the services of the Company, potentially through the implementation of ISO 9001 in the future.

RA Mission
- Development and , maintenance and improvement of Regulatory documentation
- Management of local regulatory files
- Ensuring the RA conformity of products sold
- Follow-up of the regional regulation for medical devices, cosmetics, food supplements and pharmaceutical products.

- You have a MSc. in Pharmacy or equivalent
- You have 5/8 years experience in QA/RA position, and 3 years as Manager
- You have good knowledge of the ISO 13485, GMP, and MDD93/42
- You have good knowledge of law EEC 2001/83 for pharmaceutical products
- You have good knowledge of the regulatory requirements for Medical Devices, drugs, dietary supplements, cosmetics.
- You are well organized, dynamic and willing to work within an international environment
- You speak fluently Polish and English

Please send us your application in English.