Description
We are looking for a
Quality Senior Project Manager 50% (m/f)
Reference: -en
Start: 01/17
Duration: 4 MM++
Place: in Basel-City
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- 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
Your qualifications
- 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 (oral & written); good skills in site/local language desired (oral)
Skills:
- Project manager
Keywords: Projektleiter