Description
We are looking for a German speaking Project Lead for LIMS project.Location-Bergkamen
Language-German
start-ASAP
Be responsible as site project manager for implementation of a LIMS system in a GMP environment of Quality Control.
Be responsible for stakeholder management on site, with global teams and third-party vendors
Execute LIMS implementation in budget and time together with Bayer resources and external partners, including capital planning and execution of large capital projects on site (> 1 Mi EU)
Support all project demands and supply activities in cooperation with central and site IT functions.
Have a lifecycle planning of existing and new LIMS- systems including hardware and software by working in conjunction with site system owners and ensure these systems are in validated state and meet current cGMP and IT security requirements.
Support system owners for maintaining current and future systems in a reliable (>95% uptime) and compliant manner GxP and IT Security compliance through development and execution of the project.
Ensure that the implemented LIMS-system complies to overall standards and align closely with the global program and steering committee.
Required Qualifications
Project Management experience (PMI certification)
Strong experience in Computer Systems Validation, 21 CFR Part 11, Part 820 and EMA Annex 11.
Sound knowledge of Quality System Regulation (QSR), GxP, GAMP and SDLC
as well as knowledge of cGMP, FDA, global regulatory compliance.
Experience with and high knowledge of LIMS systems
Good technical / business communication skills
Strong experience in risk assessment, gap analysis, change control and deviation management
Excellent technical writing in German
Interested candidates please share your profile at
Regards
CosMicIT GmbH