Quality Compliance Expert - Deputy Responsible Person / FvP (m/f/d)
Dieses Jobangebot ist nicht länger verfügbar.
Zug, Schweiz |
Temporary Employment
Job title: Deputy Responsible Person (40%) (m/f/d)
Industry: PharmaSkills: Quality Compliance, Deputy Responsible Person
Start of project: 01.04.2022
Duration of the project : 24 Monate
Project volume: 4032 Stunde(n)
Location: Zug, Schweiz
Tasks:
- The Deputy Responsible Person (also called “Stellvertretende Fachtechnisch verantwortliche Person”) is supporting the Responsible Person to exercise direct technical supervision and control and assures that medicinal products are handled in line with applicable regulations. Responsible Person is authorized to issue instructions and directives.
- Ensure compliance with the conditions of Swissmedic Establishment License, License for Controlled Substances, and to Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01).
- Primary contact for local health authorities: own relationship with local GDP authorities, and host inspections in Switzerland.
- All the quality relevant information received from the supplier or from the customer are communicated to the supplier or to the customer.
- Conducted and mediated processes and operations are safe
- General and batch specific documentation is retained for each batch released for trade (with respect to release to the market).
- All documents which carry the date, quantities, batch number, and exact description of the drug, name, and the address of the vendor, of delivery man and of the recipient are retainedTraceability of purchase and sales activities is guaranteed.
- Evaluation of Product Quality Reviews (PQRs).
- Provide GMP support and guidance for Atnahs and third parties employed by Atnahs.
- Review and approve any GMP or regulatory documents as required.
- Using the principles of Quality Risk Management, lead Quality Investigations root cause analysis meetings ensuring appropriated Corrective and Preventative actions have been assigned.
Qualifications:
- University degree in natural/life sciences
- Minimum 5 years working experience in the pharmaceutical industry in the field of Quality Management
- Working experience as Deputy Responsible Person would be desirable
- Fluent in German and English, good command of French
- Enthusiastic and highly motivated
Referenznummer:
Branche:
Beginn des Projekts:
Dauer:
Anstellungsart:
Kontakt
Lars Uhl
l.uhl@aristo-group.ch
+41 44 274 39 00
11095
Pharma
01.04.2022
24 Monate
Temporary Employment
