ProClinical is currently partnering with a Global Leader within the Life Science industry who have an opportunity for an experience Quality Assurance expert to join their team in Basel. You will be responsible for ensuring that the technical development and manufacturing operations of assigned Medical Devices/Combination Products are conducted in accordance with the Quality System requirements, ensuring high product quality, regulatory compliance and operational efficiency.
- 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 Good Manufacturing Process compliance.
- Accountable for monitoring, analysis and reporting of Good Manufacturing Process related Key Productivity Indicators 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 Medical Devices Quality in initiatives and cross-divisional projects.
- Perform or support inspections and audits as required.
- Provide support to Biologics Technical Development & Manufacturing line functions in Good Manufacturing Process compliance related issues in area of expertise (e.g. Medical Device standards).
- Coach and develop people; participate in recruitment of talent. Support a culture of high performance and trust. Assure that the required level of knowledge and skills is available and identify competency gaps. Establish and implement training and development plans.
- Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory Good Manufacturing Process guidelines, health authority requirements, Standard Operating Procedures, Health, Safety & Environment, etc.). Promote and enforce compliance to guidelines. If managing associates, ensure same for them.
- 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 values and behaviour including objectives setting, performance evaluations, development planning and participate in recruiting process.
Skills and 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.
- Ability to influence people, negotiate and communicate.
- Sound scientific, technical and regulatory knowledge in a specific area.
- Excellent knowledge of Good Manufacturing Process, 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 Good Manufacturing Process compliance.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Alexander Tooulas on +44 203 3193 032 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.