Gyógyszerész, szakgyógyszerész
Job purpose:
As Quality Manager/Responsible Person your mission will be to lead and manage the implementation and maintenance of the CHC Affiliate Quality System (covering GxP and other regulated activities) across the local CHC Commercial organization, to ensure that quality processes and activities in scope are executed in compliance with the CHC Global Quality standards and applicable GxP regulatory requirements. You will have exciting responsibilities such as securing delivery of safe, efficient, quality CHC products, information & services to ensure patients/customers safety and act as Quality Business partner to support business priorities. As Responsible Person, you will ensure GDP compliance of wholesale distribution activities within the CHC affiliate market place.
About growing with us – in this role you will:
- Lead and manage the implementation and maintenance of the CHC Affiliate Quality System (covering GxP and other regulated activities) across the local CHC Commercial organization, to ensure that quality processes and activities in scope are executed in compliance with the CHC Global Quality standards and applicable GxP regulatory requirements
- As Responsible Person, ensure GDP compliance of wholesale distribution activities within the CHC affiliate market place
- Secure delivery of safe, efficient, quality CHC products, information & services to ensure patients/customers safety and act as Quality Business partner to support business priorities
- Ensure that a Quality Management System has been implemented and is maintained
- Manage CHC products quality complaints received by the CHC Affiliate and perform trend analysis
- Participation in external and internal audits
- Manage CHC Affiliate regulatory inspections related to GxP processes and provide support
- Focal point of contact in front of the Competent Authorities for any CHC product quality/technical, GMP and GDP-related matter
- Responsible for GxP training, ensure the initial and continuous training programmes
- GxP and health-regulated activities related to the development, manufacturing, distribution and commercialization of all CHC drug and non-drug products contained in the CHC Affiliate portfolio
- Collaboration and support to other CHC Affiliate GxP and health regulated Functions (Regulatory Affairs, Medical, Pharmacovigilance, Supply Chain, etc.) and partnership with Business Functions across the CHC Affiliate
About you: Qualifications, education & work experience:
- University degree - Pharmacist diploma
- 3+ years work experience gained at a pharmaceutical company in appropriate Quality Assurance role (GMP and/or GDP)
- Meets local regulations for nomination of Responsible Person
- Thorough knowledge of GDP and relevant regulation
- Demonstrated ability to handle, oversee and prioritize multiple tasks
- Pro-active, customer-oriented attitude
- Flexibilty, team work
- Good written and verbal communication skills
- Knowledge & experience in Medical, Clinical, Regulatory or in Pharmacovigilance domain
- Proficiency in English, Hungarian is a must
- User level computer skills (PowerPoint, Word, Excel, Adobe)
Employment information
Position
Quality Manager - Responsible Person CHC (Opella Healthcare Commercial)
Place of work
Budapest, Magyarország
Type of work
open-ended
Start date
13 Mar 2023
Experience level
Not applicable
Type of employment
Full-time employment
Salary
Not applicable
Work experience
| Min. required experience | |
|---|---|
| Gyógyszerkészítés és értékesítés | |
| Gyógyszerek, gyógyhatású készítmények elkészítése | |
| Orvosi vény alapján előállított gyógyszerek és gyógyhatású készítmények összeállítása | |
| Gyógyszerek csomagolásának ellenőrzése, a megfelelő minőség és kiadhatóság biztosítása | |
| Kapcsolattartás | |
| Kapcsolattartás szállítókkal | |
| Kapcsolattartás hatósággal | |
| Kapcsolattartás nagykereskedőkkel | |
| Kapcsolattartás orvosokkal és egészségügyi dolgozókkal | |
| Kapcsolattartás a szakmai érdekképviselettel és kamarával | |
Required education
- pharmaceutical studies
Health sciences
Higher education Master's degree
Required language skills
- English
Computer skills
Level Office suite Database management system Advanced user Email client Advanced user Presentation programs Advanced user Word processor applications Advanced user Spreadsheet applications Advanced user Driving license
Min. required experience Driving licence category B Required soft skills
- Motivation, strive for personal success.
- Empathy, the willingness to participate in building personal relationships.
- Immediacy, ability and willingness to build personal relationships.
- Time management and priorization, the level of planned thinking and self-organizing ability.
- Relationships, willingness and ability to build personal relationships.
- Quality work, the need for accuracy and detail.
What we offer
- An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team
- An attractive, market-oriented salary aligned with your qualifications
- An individual and well-structured introduction and training of new employees
- Professional carrier opportunities in dynamically developing working environments
- As a globally successful and constantly growing company, the company provides international career paths as well
- Collective life and accident insurance
- Yearly medical check-up
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