QC Equipment Qualification Specialist (m/w/d)
Posted on Jun 16, 2020 by ITech Consult
QC Equipment Qualification Specialist - QC/English/German/English/Project Management Experience
For our customer a big pharmaceutical company in Basel we are looking for a QC Equipment Qualification Specialist
The QC Technology Innovation Implementation is looking for a QC Equipment Qualification Specialist to join the Basel team. The department is planning an e-validation tool to be launched in the US & EU over the next year. In addition to equipment qualification responsibilities, the candidate should be involved in the planning of this project.
Tasks and responsibilities:
* Support site training for "standard systems" during the rollout
* Work with sites to build Standardized URS and IOV documents as dictated by equipment type.
* Creation of "current state" to document how sites are doing qualification. Creation of "future state" benefits going forward (new way of doing business)
* Work to revise Global Standard Document documents to align with the new processes governed.
* Creation of repository of necessary supporting documents such as Supplier Assessments.
* Work closely together with development and other QC technology groups to ensure that new technologies are well document so that other sites can adopt the qualification strategy of these new technologies.
* Lead Global teams to bring together all groups impacted by "Standard systems" such as Quality Control, Manufacturing, Development, and Computer System Validation.
* Ownership and Accountability - Takes accountability for actions, drives results, learns from mistakes. Is direct and truthful and therefore widely trusted - delivers on promises, goals, and expectations. Makes quality decisions and resolves problems rapidly.
* Customer Focus - Partners with customers/stakeholders and looks ahead to predict future stakeholder needs.
* Decision Making - Demonstrates sound judgment in synthesizing data and information to make timely decisions; communicates, influences and escalates issues and decisions as needed.
* Teamwork & Communication - Contributes to an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation.
* Up to 20% Travel maybe necessary for this position.
* Min 2 to 5 years in QC Equipment qualification and/or Computer Systems Validation
* Experience in a GMP environment for Biologics or Small Molecules
* Project Management Experience
* Fluent in English AND German
* Bachelor or above in Life Science, Pharmacy or equivalent
* Experience in analytical technologies a plus
Reference No.: 919451SGR
Role: QC Equipment Qualification Specialist
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert.
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.