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QA Manager Qualification (CAPEX) / (m/f/o)
View: 142
Update day: 24-04-2024
Category: Pharmaceutical / Chemical / Biotech
Industry:
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Job content
For an international pharmaceutical company located in Vispwe are looking for a:
are looking for an experienced quality leader responsible for the equipment & facilities
qualification aspects of our CAPEX projects portfolio.
JOB DESCRIPTION:
- all quality related responsibilities for the commissioning and qualification
(C&Q) activities of dedicated new facilities, equipment and utilities related to the
GMP manufacturing of biologics & APIs - of Quality in the CAPEX project organization in regards to
qualification of facilities, utilities, equipment and systems (incl. computerized
systems) - and releases of qualification documents and SOPs
- a Subject Matter Expert (SME) and provides guidance and recommendations to
internal or external customers
ESSENTIAL REQUIREMENT / RELEVANT EXPERIENCE
- Bchelor, Master degree or PhD in biotechnology, chemistry, life science or related
field - ore than 5 years of Experience in Biotech area
- least 2 years of Experience as QA Qualification/Validation OR 5 years in CQV
position - on Drug Product (Filling Line, Isolator, depyro tunnel, Washing machine,
autoclave) and related Guidelines (e.g. ASTM, ISPE, GAMP) - experience with the PQ phase (performance qualification)
- background in cGMP
- experience in interaction with all kind of interfaces within the organization and with
regulatory agencies (Swissmedic, FDA etc.) - verbal, written and interpersonal communications skills
- in English, German would be an advantage
START DATE: asap
END DATE: till 31.12.2022 (high probability of extension)
WORK LOCATION: 3930 Visp
WORKLOAD: 100%
INTERESTED?
We look forward to your application via our homepage.
ARBEITSORT
VispBRANCHE
DiverseKONTAKTPERSON
Induserv (Nordwestschweiz) AGKarrer Thomas
Claragraben 132a
CH-4057 Basel
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Deadline: 08-06-2024
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