Beschreibung
QA Team lead vacancy for a globally operating Basel based company in the pharmaceutical sector.Your experience/skills:
- 2+ years of relevant experience in Biologics QC/AS&T or Quality Function with at least 2 years in a commercial manufacturing site
- In-depth knowledge of biological and physico-chemical protein analytics along with Subway and ESOPS skills
- Competency of analyzing, evaluating and ensuring cGMP compliance with analytical transfer requirements of analytical method transfers including HA requirements such as FDA and ANVISA
- Strong project management skills, plus the ability to influence people, negotiate and communicate effectively
- Languages: English and German, fluent in written and spoken
Your tasks:
- Ensuring that processes, documentation and systems are followed to allow effective analytical method transfers for Commercial site-to-site transfers, including CPO testing labs while collaborating close with QC and AS&T or MS&T of sending and receiving sites
- Creating and managing review and approval of transfer documentation, for example method transfer plans and reports, in the applicable document management systems, like Subway, in close collaboration with the sending and receiving sites
- Preparing and coordinating material and sample shipments required to support analytical method transfers and comparative testing
- Assessing test methods and testing monographs plus sustaining compliance of all analytical transfer activities with current official regulations, pharmacopeias, QM, QD, GOP, STD and SOP relevant for analytical method transfers
- Providing statistics and test results evaluation to support decision-making during method transfer while also contributing to investigations and aiding with troubleshooting
- Managing the stability program support associated with transfers including results evaluation, reporting and trending
Start:
Duration: 10MM+
Location: Basel, Switzerland
Ref.Nr.: BH16676
Does this spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.
Going the Extra Mile.
As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.
Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
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