Quality Assurance Process Engineer Specialist
hace 4 días
About the Job
At Robert Walters Spain, we are seeking a highly skilled Quality Assurance Process Engineer Specialist to join our team. This role offers an excellent opportunity for professionals with expertise in quality assurance and process engineering to take their career to the next level.
Salary: €50,000 - €65,000 per year, depending on experience
Job Description:
We are looking for a Quality Assurance Process Engineer Specialist responsible for ensuring the effectiveness of our Quality Management System (QMS) and maintaining compliance with current legislation and regulations. The successful candidate will work closely with product managers, project managers, and developers to ensure quality is maintained at every lifecycle stage.
Key Responsibilities:
- Drafting and reviewing documentation related to QMS processes;
- Participating in the maintenance of risk analysis of QMS processes;
- Tracking and maintaining key performance indicators (KPIs);
- Frequently inspecting the production plant to verify on-site process control and compliance with procedures;
- Training staff on modifications to be made;
- Organizing and convening quality meetings as required;
- Identifying and proposing opportunities for improvement of the Quality Management System;
Your Tasks Will Include:
- Related to manufacturing transfer process: Transfer from design to production regarding control plans/control methods; Training of factory personnel; Support to design and construction of test rigs for design and/or manufacturing; Change controls relating to in-house and subcontracted manufacturing process (assembly, control).
- Related to validation process: Writing protocols, participating in the execution and reporting of validations; Monitoring the progress of the validation plan and reporting to your manager; Preparation of validation maintenance reports and monitoring of equipment, facilities, and services; Evaluation of trends; Validation of clean rooms; Validation of ethylene oxide and wet steam sterilisation systems; Validation of computerised systems; Validation of test methods based on advanced analytical techniques; Validation of transport.
- Related to risk analysis process: Maintenance and updating of facility and process risk analyses; Review of current procedures and protocols to ensure alignment with GMP annex 15 on qualification and validation.
- Related to calibration process: Monitoring the progress of the calibration plan and reporting to your manager; Development and updating of calibration procedures; Participation in the execution and issuing of calibration reports; Control of the spreadsheets of uncertainties, errors, etc.
Requirements:
The ideal candidate will have more than 3 years of experience in the quality assurance area, specifically process engineering, preferably at least two years in a medical device and/or pharmaceutical company.
Benefits:
We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.
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