Your new role
As QA Specialist Quality Engineering, you will support the day-to-day quality operations of all elements of the Quality Management System (QMS), including deviations, Corrective and Preventive Actions (CAPAs), investigations, excursions, Out of Specifications (OOS), change control, and data integrity with a focus on quality engineering and validation aspects of biologics manufacturing production.
Other tasks include:
- Performing reviews of Validation Lifecycle documents including Functional, Detailed Design, Configuration and User Requirement Specifications (FS/DDS/CS/URS) and Factory and Site Acceptance Test (FAT/SAT) protocols and Reporting from a quality perspective to ensure compliance to internal requirements.
- Performing reviews of protocols and reports relating to Facilities, Utilities, and Equipment commissioning and qualification/requalification, process/method validation, and other cGMP activities from a quality perspective to ensure compliance to internal requirements and sound technical rational.
- Reviewing and approving deviations and CAPAs, including performing Failure Mode Effect Analyses (risk assessments), participating in root cause analysis investigations, evaluating CAPA effectiveness, and overseeing departmental training.
- Reviewing and approving change controls with a focus on those pertaining to equipment, facilities, utilities, and process changes ensuring validation impact, procedural impact, regulatory impact, and prescribed testing is adequate and well justified.
- Performing the review and approval of commissioning and qualification documentation for facilities, equipment, and utilities.
- Reviewing and approving preventative maintenance, calibration, and work order documentation.
- Supporting internal and external audits.
- Representing Quality Assurance on project teams and in meetings.
- Supporting the continuous improvement and oversight of Quality Management System procedures.
- Providing any additional QA support as necessary (e.g. Review and approve batch records).
To be successful as QA Specialist Quality Engineering, you have a Bachelor’s Degree in Life Sciences or Engineering, combined with at least 4 years of relevant GMP experience in a pharma/biotech company. You have experience working within a quality system and in a regulated GMP environment. You are well versed in cGMP/ICH/FDA/EU regulations and guidelines. IT wise you need to be proficient in using Microsoft applications (MS Word, MS Excel, MS Powerpoint). You are fluent in English, Dutch is not mandatory for this position. You need to be available fulltime (40 hours per week) for this position and your presence is requested on site in Amsterdam.
About the organization
Your new company is based in the Amsterdam area and focuses on making the future of medicine better using gene therapy. By doing so, they help patients with serious unfulfilled medical needs. This means that you will, indirectly, contribute to helping those patients and potentially giving them a better life. On a daily basis you will contribute to this as well. The company is continuously looking for highly motivated and skilled people who are willing to make a difference.
You will work in an international and dynamic environment with many opportunities to grow your career for the long term. The salary depends on your education and experience and they offer great secondary benefits, such as 30 holidays, travel expenses, stock options, a good pension scheme, a monthly allowance for your health insurance, an annual personal education budget and a company fitness plan. It’s an amazing environment, will you join them as a QA Specialist Quality Engineering?
What you need to do now
Are you interested in this vacancy as QA Specialist Quality Engineering? Click on 'Apply' and send an up-to-date CV or call Merel Hasselo on +31620076590. If this vacancy is not exactly what you are looking for, but you are looking for a different position, please contact us for a confidential discussion about your career options. #1045863