Quality Equipment Specialist
Temporary Contract / Limited Contract
Oegstgeest
15 May 2025
We are looking for an Quality Equipment Specialist for our Akkodis team, at our customer in Leiden.
Start: A.S.A.P. Assignment for 6 months (could be renewed after this period).
Responsibilities
The Quality Equipment Specialist is responsible for providing quality oversight and support for equipment lifecycle activities, including selection, design, commissioning, qualification, calibration, maintenance, and decommissioning. This role ensures that equipment used in manufacturing, laboratories, and support systems complies with regulatory requirements, company procedures, and industry best practices.
Your mission
- Provide quality oversight and approval for equipment lifecycle documentation including URS, DQ, IQ, OQ, PQ, and change control.
- Collaborate with Engineering, CQV, and Maintenance teams to ensure that equipment meets intended use and quality standards.
- Review and approve commissioning and qualification protocols and reports, ensuring compliance with cGMP and relevant guidelines (e.g., FDA, EMA, ISO, ICH).
- Ensure that critical equipment and instrumentation are properly calibrated and maintained in accordance with approved procedures.
- Participate in risk assessments (e.g., FMEA) related to equipment and process qualification.
- Support deviations, CAPAs, and change control related to equipment and ensure timely resolution.
- Monitor and trend equipment-related quality data and recommend improvement actions.
- Ensure data integrity and adherence to ALCOA+ principles in equipment documentation and systems.
- Support audits and inspections by providing relevant equipment documentation and subject matter expertise.
Company Details
We are Akkodis. We put the talents, skills and ambitions of our consultants first! Because we continuously offer challenging projects, you will develop quickly and you can realize your ambitions with us. Akkodis Life Sciences offers internal and external projects in the field of Quality Assurance, Quality Control, Pharmacovigilance, Regulatory Affairs, Research & Development, Supply Chain, etc.
Currently, more than 60 consultants work at the EMA, Astellas, GSK, Unilever, RIVM, MSD, Organon, Aspen and many others!
Candidate Profile
You will bring with you:
- Bachelor’s degree in Engineering, Life Sciences, or related technical field.
- 3–5 years of experience in a quality, validation, or engineering role in the pharmaceutical, biotech, or medical device industry.
- Strong knowledge of cGMP regulations, FDA 21 CFR Part 11, ISO 13485 (if applicable), and industry guidance such as ISPE and ASTM E2500.
- Experience with laboratory, manufacturing, and/or facility equipment validation and qualification.
- Working knowledge of calibration systems, CMMS, and quality systems (e.g., TrackWise, Veeva).
- Strong attention to detail, problem-solving, and communication skills.
Sounds interesting? Does this position sound like the perfect step in your career?
Then apply through one of our Talent Acquisition Specialists.