A job vacancy for a QA/QC Expert has arisen at a leading global pharmaceutical company specialising in the development of biological therapies. This company is one of the top 10 global pharmaceutical companies that operates in 140 countries worldwide and has market leading products in multiple therapy areas.
- Ensuring technical development and manufacturing operations of assigned Medical Devices/Combination products are conducted in accordance with the company's quality system requirements, ensuring high product quality, regulatory compliance and operational efficiency.
- Managing portfolio of assigned projects, support a discipline and/or provide a service on his/her own or with a team of associates.
- Providing functional expertise in area of responsibility for medical devices and combination products.
- Writing, Reviewing and approving 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.
- Accountable for monitoring, analysis and reporting of GMP related KPIs as part of management reporting.
- Managing quality problems and technical matters and ensure they are resolved consistently and in accordance with global standards and policies.
- Releasing of medical devices for clinical studies and commercial use.
- Supporting Medical Device Risk Management, through proactive risk management tools and approaches, to minimise impact on global supplies and patients.
- Representing MD Quality in initiatives and cross-divisional projects.
- Leading project related activities (e.g. development of new tools, processes).
- Performing or supporting inspections and audits as required.
- Providing support to BTDM line functions in GMP compliance related issues in area of expertise (e.g. Medical Device standards).
- Coaching and developing people and participating in recruitment of talent.
- Supporting a culture of high performance and trust.
- Assuring that the required level of knowledge and skills is available and identify competency gaps.
- Establishing and implementing training and development plans.
- Meeting internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority requirements, SOPs, HSE, etc.) Promoting and enforcing compliance to guidelines. If managing associates, ensuring the same for them.
- Supporting project management functions as a sub-team member in preparation for a Pre-Approval Inspection.
- Writing/contributing to internal compliance policy and/or comment to regulations.
- Leading and supporting direct reports in line with the company's 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 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.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact James Wilson at +44 203 762 2703 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.