ProClinical is currently recruiting for a Senior QA Specialist job at a leading multinational biopharmaceutical company with leading therapies in autoimmune diseases and oncology. They are seeking an individual to bring solid quality assurance experience their team at their offices in the Netherlands. This is an exciting opportunity to work for one of the world's biggest biotechnology firms that employs over 17,000 staff globally.
- Perform QA support and oversight for equipment, automation and IS validation. This function does NOT develop the technical solutions.
- The QA validation specialist will work under supervision of Clients staff. Level of independency will vary based on familiarity with the subject (e.g. equipment, automation, etc).
- Expectation is that staff can perform selected QA validation activities within one month from starting date.
- Perform review and approval of equipment and automation validation documentation, ensuring that Corporate, Site and Regulatory requirements are met.
- Keeps quality oversight on validation strategy and deliverables for specific projects.
- Maintain a close contact and familiarity with Clients Quality systems.
- Provide guidance and direction to Quality, Production, Warehouse/Distribution and Supply Chain staff in regards to compliance with quality policies, standards and procedures.
Education and Experience:
- Master Degree in Engineering, Pharmaceutical sciences, Process Technology, or equivalent
- 10 years of professional experience in GMP environment
- 5 years relevant experience in Equipment and Automation Validation, preferably related to secondary packaging
- Additional experience with Non Conformances, CAPA's and Change Control
- Expanding knowledge of GMP, equipment and automation/IS validation, computer compliance (Annex 11, Part 11)
- Good attention to detail and excellent writing skills in English language
- Effective communication skills at multiple levels and areas (inside and outside of Quality)
- Good decision making skills and ability to apply risk based approach. Familiar with risk management tools such as FMEA, etc.
- Logical and linear analytical skills to evaluate and interpret complex situations/problems using multiple sources of information
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 Nick Dietz on +44 203 3193 033 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.