Job Description for Quality Officer
Oystershell seeks a Quality Officer to support the Quality Manager in various tasks.
Key Responsibilities:
* Coordinate the release of final products for Medical Devices and non-Medical Devices, ensuring compliance with regulatory requirements.
* Release article cards and bill of material (BOM) in our Enterprise Resource Planning (ERP) system.
* Manage the release of specific raw materials and primary/secondary packaging materials.
* Assist in dummy recalls and supplier management activities, including batch record reviews, supplier qualification, and evaluation.
* Provide administrative support to the Quality Manager for general supplier and product management, including reports on recurrent meetings, follow-up on action items, CAPA's, deviations, etc.
* Support change control, process validation, and pilot batch production activities, including administrative tasks, preparation of reports, and communication with Contract Manufacturing Organizations (CMO).
* Review and approve '02 PRFI's and underlying documents.
* Contribute to the creation of manufacturing instructions, flowcharts, 08- and 10 PRFI's, test methods, and specifications.
* Perform supplier audits to ensure quality standards are met.
* Support the Quality Manager in stability management activities.
* Calibrate and verify laboratory equipment at Oystershell's laboratory.
* Register, investigate, and report non-recurrent complaints.
* Review and approve invoices, initiate purchase orders, and manage waste and retain samples.
* Act as a backup for the Quality Assistant (excluding Document Administration).
Requirements:
Education & Experience:
* Bachelor's Degree in Sciences (Pharmaceutical Sciences, Biomedical Sciences, Bioengineering) or equivalent experience.
* Proven experience in a quality department or laboratory role.
* Background in pharmaceuticals or chemistry.
Technical Skills:
* Excellent proficiency in Dutch and English languages.
* Familiarity with ISO standards; knowledge of ISO13485 is an asset.
* Experience with root cause analysis, CAPA, complaint handling, stability testing, change control/MOC, and deviations.
* Proficiency in Microsoft Office tools (Outlook, Word, Excel).
* Affinity with ERP/DMS packages.
Competencies & Expected Professional Attitude:
* Mature, positive personality with a love for challenges.
* Passionate and strong organizational/administrative skills.
* Accurate and structured work approach.
* 'Can-do' and hands-on mentality.
* Respect for deadlines and efficient work habits.
* Traits of a team player with excellent communication skills to ensure seamless cooperation within the company.
* Commitment to upholding Oystershell's quality standards as outlined in the quality policy.
This is a unique opportunity to take your career to the next level. If you're ready for the challenge, submit your CV and motivation letter.