The Company
Our client is a top-tier global healthcare company specializing in medical devices, pharmaceuticals, and vaccines. They are dedicated to advancing human health and saving lives through innovative products and services. Join their maintenance team, a dynamic group of skilled professionals collaborating to ensure the reliability, safety, and efficiency of their facilities.
About the Role
Our client, a leading organization dedicated to delivering top-quality products, is looking for a Quality Assurance Specialist to join their team in Leiden. In this role, you will ensure that products and processes consistently meet high-quality standards, contributing to continuous improvement and supporting the company’s commitment to excellence.
Key Responsibilities
-Facilitate the ongoing improvements program within EVM.
-Serve as the subject matter expert for validation activities.
-Support all EVM sub-groups in optimizing and aligning their internal processes and communication.
-Apply advanced industry and process excellence methodologies (e.g., Six Sigma, Green Belt) at an expert level.
-Implement and maintain a system to visualize EVM performance, metrics, key milestones, and actions, including sub-department trends.
-Lead processes to safeguard EVM’s performance within GMP boundaries.
-Provide complex team support to all EVM sub-groups for handling and following up on CAPAs, events, deviations, and related quality matters.
-Ensure comprehensive measurement systems are in place to monitor the effectiveness of quality and critical systems.
-Proactively engage with all EVM business partners to align and optimize interactions.
-Conduct and follow up on internal audits.
-Act as the Quality representative for EVM.
-Advise engineering and maintenance teams on applying Process Excellence (PE) methodologies in maintenance and project execution.
Candidate Profile
-Minimum 4-8 years work experience in similar role as a quality engineer or experience in GMP environment related to Process Excellence and Quality.
-Understanding of regulatory requirements and industry guidelines specific for the pharmaceutical industry and Validation (e.g FDA, GMP, ICH, ASTM, ISPE, etc.)
-Fluent in English; proficiency in Dutch is an advantage.
Other Information
Are you interested and would you like to apply for this position? Please submit your application using the application button below and contact Zahra Souhali.
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About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
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