Proclinical is advertising a vacancy for a Quality Engineers, Validation Consultant position with one of the world's most prestigious pharmaceutical companies. This organisation, which works across a range of industries from medical devices to pharmaceutical and consumer goods, is seeking applicants for its office in Switzerland on a contract basis.
The Quality Engineer will support process validation strategy, writing and executing engineering studies whilst processing validation protocols and summary reports (Installation, Qualification, Operation Qualification, Performance Qualification, Computer Software Validation, and Test Method Validation).
Job Responsibilities:
- Supporting process validation strategy, writing and executing engineering studies, process validation protocols, and summary reports (Installation Qualification, Operation Qualification, Performance Qualification, Computer Software Validation, and Test Method Validation).
- Developing and implementing control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, and 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 determining adequacy of current process limits.
- Ensuring the development of a comprehensive risk management plan for the product and process.
- Documenting, justifying, reviewing, and 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 non-compliance 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, and process controls; Determining 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 investigations, bounding, documentation, reviews and approvals of non-conformances, CAPAs, and customer complaints; escalating quality issues as appropriate.
- Supporting Base Business and Production Improvement Initiatives.
- Knowing and following all laws and policies that apply to one's job and maintaining the highest levels of professionalism, ethics, and compliance at all times.
Skills and Requirements:
- A BS in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree.
- Four to six years of experience in quality engineering.
- Experience with ISO 9000, ISO 13485, and GMP.
- Experienced in Design and Process validation.
- Knowledge of Quality Tools.
- Previous experience with working in a regulated industry, such as Medical Device is preferred.
- Sig Sigma or Lean Sigma certification, or four years of experience preferred.
- Experienced with packaging, Laser, and CNC processes and equipment preferred.
- Proficiency in German highly desirable.
- 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.
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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