ProClinical is currently recruiting for a Specialist Manufacturing 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 Breda. This is an exciting opportunity to work for one of the world's biggest biotechnology firms that employs over 17,000 staff globally.
- Support primary production process
- Work within full GMP compliance
- Own NCs , CAPAs, CAPA-EVs and Change records
- Perform NC root cause investigations and define CAPA actions
- Perform change assessments for Production area
- Effectively manage CAPA and Change implementation plans
- Ensure timely closure of Production owned records
- Determine and implement responses related to audit observations
- Own, review and approve SOPs where appropriate
- Improve quality and performance
- Develop and improve performance measurement models that effectively measure process performance and/or service levels (e.g. OEE tool)
- Collaborate with Production staff to create and maintain meaningful line control charts
- Actively participate in continuous improvements initiatives (e.g. Kaizen)
- Create proposals and implement initiatives to:
- Prevent recurring NCs
- Improve overall process quality
- Reduce hard work for Production staff
- Increase process stability
- Collaborate with /coach Sr Associates Manufacturing on improvements & problem solving
- Lead assigned projects to successful completion (on time, within budget)
- Assist in the roll-out and implementation of new production concepts
- TrackWise (NC/CAPA and Change Control) - EDM-Quality - SAP - MS Office
Skills and Requirements:
- Bachelor degree in Industrial Engineering or Engineering
- Minimum of 3-5 years’ experience in the field of Industrial Engineering and performance analysis
- Minimal 3 years’ experience in pharmaceutical or similar environment
- Good knowledge and understanding of Good Manufacturing Practices
- Proven experience with Lean principles (Kaizen process improvements)
- Knowledge of problem solving techniques
- Fluent in English, both oral and written communication
- Preferred Requirements
- Experience in owning and writing NCs/CAPAs
- Experience in project management
- Experience in a supply chain environment
- Knowledge of World Class Manufacturing tools (JIT / 6 Sigma / Design For Manufacturing / SPC / FMEA / RCA)
- Familiar with ERP & WMS Systems
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 Will Hitchcock on +44 203 0789 554 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.