Quality Expert for Medical Devices
CK QLS are recruiting for a Quality Expert to join a company in the Medical Device (Combination Products) department for a global healthcare company at their site based in Basel on a contract basis for 12 months.
Quality Expert Role: The main purpose of the role will be to:
- Manage portfolio of assigned projects, support a discipline 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 (e.g. procedures, records, third party work, contractors, clinical trial material, components) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance.
- Manage quality problems and technical matters and ensure they are resolved consistently and in accordance with global standards and policies.
Further responsibilities will include:
- Supporting Medical Device Risk Management, through proactive risk management tools and approaches, to minimize impact on global supplies and patients.
- Leading project related activities (e.g. development of new tools, processes).
- Writing/contributing to internal compliance policy and/or comment to regulations.
- Leading and supporting direct reports in line with Novartis values and behaviour including objectives setting, performance evaluations, development planning and participate in recruiting process.
Your Background: In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Graduate in Chemistry, Pharmacy, Microbiology or Biotechnology or another related science.
- Fluent German and English Skills, French is desirable.
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.
This is an excellentopportunity to join a leading pharmaceutical and medical device company.
Apply: For more information or to apply for this Quality Expert position, please contact Jocelyn Blackham on 0041 (0) 782 516 595 or email jblackham@ckqls.ch, quoting job ref 50049.
Please could you send any correspondence in English.
It is essential that applicants hold entitlement to work in Switzerland.
