Quality Senior Project Manager 50% (m/f)

REFERENZNUMMER:

324887/11

IHRE AUFGABEN:

-Manage portfolio of projects (third parties, analytical instruments and manufacturing equipment as per area of responsibility)
-Review and approve deliverables as well as write, review and approve documents to ensure GMP compliance
-Represent TRD QA in initiatives
-Lead project related activities
-Perform inspections and audits as required
-Contribute to the evaluation of new QA tools
-Provide support to TRD line functions in GMP compliance related issues in area of expertise
-Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority guidances, SOPs, HSE, etc)
-Support project management functions as a sub-team member or in preparation for a PAI
-Write/contribute to internal compliance policy and/or comment on regulations

IHRE QUALIFIKATIONEN:

-Basic degree in science or relevant discipline (BSc or equivalent) or advanced degree in science or relevant discipline (MSc or equivalent)
-Good knowledge of cGMP, working knowledge in technical development, production or QA
-Sound scientific, technical and regulatory knowledge
-Broad working experience in TRD, production or QA
-Good organizational skills
-Good and proven ability to analyze and evaluate GMP compliance
-Fluent English skills required (oralgood skills in site/local language desired (oral)

WEITERE QUALIFIKATIONEN:

Project manager