Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.
Vakante Jobangebote finden Sie unter Projekte.
Quality Manager, Teamleader QA
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Client, Support
Projektbeschreibung
We are looking for our client in Basel for a Quality Manager, Teamleader QA for a 5 month project.
Place: Basel
Period: ASAP-31.01.2016
Workload: 60%
General tasks
* Ensure that the life cycle of equipment and premises as well as facilities related to and used for the manufacture, packaging and storage of clinical material comply with internal guidelines and SOPs and the state of the art of international standards from planning till re-tirement.
* QA oversight of Qualification and Validation activities in manufacturing sites of TRD CH.
* Ensure and control that the corresponding elements of the corporate GMP Quality Manual are appropriately implemented and are appropriately followed by the different areas of operation.
* Contribute to the development of standards for qualification in TRD.
* Advise Line Units with regards to qualification of equipment and premises/facilities.
Individual tasks
* Developing and maintaining policies and SOPs with regard to qualification of equipment and premises/facilities.
* Advise Line Units with regard to qualification plans and reports. Control and approve related documents.
* Support line functions during their qualification/validation efforts.
* Interpretation of new regulatory requirements, evaluate their impact and coordinate imple-mentation.
* Check deviations resulting from qualification activities and execute their follow up and com-pletion.
* Approving change requests and release of the corresponding equipment/facilities.
* Control that the related service providers and suppliers appropriately comply with corre-sponding set of standards.
Education
minimum/desirable: Minimum: Basic degree in science or relevant discipline (BSc or equivalent) Desirable: Advanced degree in science of relevant discipline (MSc or equivalent)
Languages:
Fluent English required (oral & written).
Good skills in site (local) language desired (oral).
Experience/Professional requirement:
Good knowledge of cGMP, working knowledge in technical development, production or QA.
Sound scientific, technical and regulatory knowledge.
Broad working experience (min. 5 years) in TRD, production or QA (eg several years of experience as head of laboratory).
Good organizational skills.
Good and proven ability to analyze and evaluate GMP compliance.
For more information, please contact:
Moritz Dewald
(see below)
Place: Basel
Period: ASAP-31.01.2016
Workload: 60%
General tasks
* Ensure that the life cycle of equipment and premises as well as facilities related to and used for the manufacture, packaging and storage of clinical material comply with internal guidelines and SOPs and the state of the art of international standards from planning till re-tirement.
* QA oversight of Qualification and Validation activities in manufacturing sites of TRD CH.
* Ensure and control that the corresponding elements of the corporate GMP Quality Manual are appropriately implemented and are appropriately followed by the different areas of operation.
* Contribute to the development of standards for qualification in TRD.
* Advise Line Units with regards to qualification of equipment and premises/facilities.
Individual tasks
* Developing and maintaining policies and SOPs with regard to qualification of equipment and premises/facilities.
* Advise Line Units with regard to qualification plans and reports. Control and approve related documents.
* Support line functions during their qualification/validation efforts.
* Interpretation of new regulatory requirements, evaluate their impact and coordinate imple-mentation.
* Check deviations resulting from qualification activities and execute their follow up and com-pletion.
* Approving change requests and release of the corresponding equipment/facilities.
* Control that the related service providers and suppliers appropriately comply with corre-sponding set of standards.
Education
minimum/desirable: Minimum: Basic degree in science or relevant discipline (BSc or equivalent) Desirable: Advanced degree in science of relevant discipline (MSc or equivalent)
Languages:
Fluent English required (oral & written).
Good skills in site (local) language desired (oral).
Experience/Professional requirement:
Good knowledge of cGMP, working knowledge in technical development, production or QA.
Sound scientific, technical and regulatory knowledge.
Broad working experience (min. 5 years) in TRD, production or QA (eg several years of experience as head of laboratory).
Good organizational skills.
Good and proven ability to analyze and evaluate GMP compliance.
For more information, please contact:
Moritz Dewald
(see below)
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
IT Entwicklung, Sonstiges