Proclinical is advertising a vacancy for a Quality Engineers, Validation Consultant position with an internationally renowned pharmaceutical company that works across a range of industries from medical devices to pharmaceutical and consumer goods. The QE Validation Consultant will join this organisation in their office based in Switzerland.
The QE Validation Consultant will support manufacturing operations in the areas of process development, tool design, machine programming & layout, machinery & equipment, continuous improvement, and other duties associated with engineering support of production.
Job Responsibilities:
- Supporting process validation strategy, writing and executing engineering studies and process validation protocols and summary reports.
- Developing and implementing control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
- Developing and implementing appropriate process monitoring and control methods consistent with the level of process/product risk.
- Assessing and interpreting common versus special cause variation in manufacturing processing and determine adequacy of current process limits.
- Ensuring the development of a comprehensive risk management plan for the product and process
- Documenting, justifying, reviewing or analysing whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential noncompliance to a required standard, such as the QSRs
- Assessing the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.; determining the effectiveness of these techniques on previously implemented improvements.
- Assisting in the development of manufacturing and inspection procedures.
- Supporting the Manufacturing Organization in creating, reviewing, and releasing MPI & Risk Management Activities
- Originating/overseeing/assisting in the creation & release of change orders (COs) through Agile PLM software.
- Conducting investigation, bounding, documentation, reviews, and approvals of non-conformances, CAPAs, and customer complaints.
- Escalating quality issues as appropriate.
- Supporting Base Business and Production Improvement Initiatives.
Skills and Requirements:
- A B.S. in Manufacturing, Engineering, Mechanical Engineering, Industrial Engineering, or a related degree.
- Six years of experience in quality engineering.
- At least five years of relevant experience.
- Experience with ISO 9000, ISO 13485, and GMP.
- Experience in Design and Process Validation.
- Experience in a regulated industry, such as Medical Devices, is preferred.
- Six Sigma or Lean Sigma certification or four years of experience is preferred.
- Experience with packaging, Laser, and CNC processes and equipment is preferred.
- Proficiency in German.
- Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solve problems.
- 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 in MS Office.
To Apply:
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 Caleb Mensah at +44 203 854 1080 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.
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