Quality Control Specialist (m/w/d)

Basel  ‐ Vor Ort
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Beschreibung

Quality Control Specialist (m/w/d)- cGMPs / Laboratory / project management / pharmaceutical industry /Englisch

Project:
For our customer F. Hoffman La Roche in Basel we are looking for a Quality Control Specialist

Background:
We are the liaisons to the external network for analytical topics and provides expertise and oversight for external testing of Roche commercial products manufactured at CMOs. We support the analytical aspects of the product life cycle including method, and specification management across more than 50 CMOs and Contract Laboratory Organization (CLOs). We collaborate with the internal network to implement and maintain QC processes and methods, qualify independent data review, and resolve analytical issues to enable the CMO/CLO to consistently meet Roche requirements and health authority expectations.

As a Member of the External Quality group, the QC-Specialist:
* Is Subject Matter Expert in Quality Control and stability related topics, investigations and issues.
* Is responsible for the maintenance and revision of Roche specifications and methods for products manufactured at CMOs including assessment and implementation of new regulatory requirements. Is responsible for the information of quality site management for implementation at the CMOs.
* Supports change control for Specifications, Analytical methods, Stability protocols, and other laboratory impacting activities.
* Supports the Local and Global Change Commission regarding changes in Analytics and Methods impacting a CMO.
* Provides quality oversight of QC related activities performed at CMOs for Roche products.
* Reviews and assesses QC activities at CMOs against cGMPs, regulatory dossiers, Roche Quality Requirements and Global Standards and Practices.
* Reviews CMO stability protocols and reports.
* Support of analytical transfer activities (e.g. support in providing documents, samples, reference standards).
* Contribution to the elaboration of quotes/purchase orders for analytical activities.
* Analytical support for regulatory submissions and HA requests in collaboration with the product quality team.

Must haves:
* Minimum of 5 years of experience in Quality Control or Analytical Development including Laboratory experience (activities or supervision)
* M.S. in Science or equivalent (chemistry, biotechnology) Graduate degree preferred.
* Excellent English in writing and speaking another European language such as German, French or Italian is a plus.
* Minimum 3 years of experience in project management in a pharmaceutical environment.
* Strong knowledge of global pharmaceutical industry regulations, standards and guidance documents.
* Flexibility in work hours and travel (up to 20%) to meet business objectives.
* Experience in working with multifunctional, multicultural, and global teams.

Reference No.: 919340SGR
Role: Quality Control Specialist
Industry: Pharma
Location: Basel
Workload: 100%
Start: 15.06.2020
Duration: 12++

Should you find yourself suitable for this position then please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert or to jobs[at]itcag[dot]com.

Contact us for further information regarding our company, our positions or our attractive payroll-only-program: .
About us:
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT and Life Science candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.
Start
06/2020
Dauer
12++
(Verlängerung möglich)
Von
ITech Consult AG
Eingestellt
13.05.2020
Projekt-ID:
1927512
Vertragsart
Freiberuflich
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