пропозиції роботи
Andrzej Murdza
Quality Control-Specialist Authorised Person for Release APIs, ICN Polfa Rzeszow S.A. Group of Valeant
Rzeszów,
podkarpackie
Dołącz do GoldenLine i obejrzyj pełny profil tego użytkownika
Zobacz pełny profil
Języki
angielski
biegły
Doświadczenie zawodowe
Quality Control-Specialist Authorised Person for Release APIs
ICN Polfa Rzeszow S.A. Group of Valeant
Release of API, CTD documentation
Key User of SAP ERP, SAP ATTP Quality Module
Key User of SAP ERP, SAP ATTP Quality Module
Manager of Quality Assurance
RCKK Rzeszow (blood establishment)
Build and development Quality Control &Qality Assurance System
Quality Control-Senior specialist
Polfa Kutno S.A. Group of TEVA
responsible for release raw and packaging materials
R&D – specialist
Polfa IVAX Kutno S.A.
Projekty
Quality Management in Production Processes. Lecturer at the CSP WSiZ posgraduated school.
Zakres obowiązków
Participation in building a postgraduate program of Quality Management in Production Processes
Szkolenia i kursy
- Certified auditor in Integrated Quality Systems, Environment, Health and Safety: ISO - 9001; ISO 14001; ISO 18001
- Module 3 and 2.3 of the CTD in the national procedure as well as DCP and MRP procedures - the latest applicable requirements and projected changes in this area -11.2014
- MRP and Decentralized procedure-registration requirements and quality of product Conference Development Centre 20.11.2013
- Good Manufacturing Practice “Auditing the API Manufacturer” –Interactive Consulting Associates GmbH Switzerland- Dr Paul Scherer 28-29.04.2011
- Good Weighting Practice In the Pharmaceuticals Industry – United States Pharmacopoeia John P. Santell „A Risk-Based Approach 11.03.2010 Vienna/Austria
- The international televised course “A Sustainable Baltic Region” Uppsala University Sweden.
- „Stability study” GMP Project Oinpharma
- Module 3 and 2.3 of the CTD in the national procedure as well as DCP and MRP procedures - the latest applicable requirements and projected changes in this area -11.2014
- MRP and Decentralized procedure-registration requirements and quality of product Conference Development Centre 20.11.2013
- Good Manufacturing Practice “Auditing the API Manufacturer” –Interactive Consulting Associates GmbH Switzerland- Dr Paul Scherer 28-29.04.2011
- Good Weighting Practice In the Pharmaceuticals Industry – United States Pharmacopoeia John P. Santell „A Risk-Based Approach 11.03.2010 Vienna/Austria
- The international televised course “A Sustainable Baltic Region” Uppsala University Sweden.
- „Stability study” GMP Project Oinpharma
Edukacja
- Postgraduate studies in Quality Management, studia podyplomowe
WSIZ Rzeszów
chemia, magisterskie
- University of Marie Curie Sklodowska in Lublin: chemistry
Inne
- Certification and batch release of APIs (complaints and recalls, review of technical document and PQR)
- Perform and coordinate transfer of analytical method for finished product
- Developed synthesis of APIs
- Auditor of GMP (internal and external)
- Prepare and approve Common Technical Document especially module 3 (for product as well as for API),CP, DCP and MRP procedure
- Elaborate of specifications, analytical method and stability report
- Validation of analytical method
- Knowledge concern guidelines ICH, EMEA, WHO and CPMP
- Perform and coordinate transfer of analytical method for finished product
- Developed synthesis of APIs
- Auditor of GMP (internal and external)
- Prepare and approve Common Technical Document especially module 3 (for product as well as for API),CP, DCP and MRP procedure
- Elaborate of specifications, analytical method and stability report
- Validation of analytical method
- Knowledge concern guidelines ICH, EMEA, WHO and CPMP
Grupy
Praca w branży medycznej i farmaceutycznej
medycyna, farmacja - oferty pracy, opinie o pracodawcach, informacje o branży
