Description
For our client a market leader in the Pharmaceutical and Medical Device Industry, i am currently looking for candidates with strong expertise in:QA / QC Expert
Project duration:
Location: Basel
Responsibility's & Task's:
- Portfolio management of assigned projects
- Support and/or provide a service on his/her own or with a team of associates.
- Provide functional expertise in area of responsibility for medical devices and combination products.
- Write, Review and approve deliverables and related tools to ensure GMP compliance.
- Monitoring, analysis and reporting of GMP related KPIs as part of management reporting.
- Manage quality problems and technical matters and ensure they are resolved consistently and in accordance with global standards and policies.
- Release of medical devices for clinical studies and commercial use.
- Support Medical Device Risk Management, through proactive risk management tools and approaches, to minimize impact on global supplies and patients.
- Represent MD Quality in initiatives and cross-divisional projects.
- Lead project related activities.
- Perform or support inspections and Audits as required.
- Provide support to BTDM line functions in GMP compliance related issues in area of expertise
- Meet internal and external guidelines regarding quality and safety
- Promote and enforce compliance to guidelines.
- Support project management functions as a sub-team member in preparation for a Pre
Approval Inspection
- Write/contribute to internal compliance policy and/or comment to regulations.
- Lead and support direct reports in line with company's values and behaviour including objectives setting, performance evaluations, development planning and participate in recruiting process.
Requirements:
- Graduate in Chemistry, Pharmacy, Microbiology or Biotechnology or another related science
- English fluent in speaking / writing
- German and/or French desirable
- At least 3 years of relevant experience.
- Sound scientific, technical and regulatory knowledge in a specific area.
- Excellent knowledge of cGMP, working knowledge of medical device and combination product regulations, standards and guidelines.
- Good knowledge of medical device development and life-cycle management.
- Good and proven ability to analyse and evaluate GMP compliance.
- High experienced in QMS
If this or similar positions could be of interest to you, please don't hesitate contact me or send me your updated CV to.
Sabina Keel
Senior Candidate Relationship Manager
Medical Devices Pharma & Biotech
Real Ein Geschäftszweig der SThree GmbH Talstrasse 65, Zurich, 8001, Switzerland ------------------------------------------------
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Sthree Switzerland is acting as an Employment Business in relation to this vacancy.