Product Quality Assurance Technician

vor 3 Wochen

PlanlesOuates, Schweiz Aptissen Vollzeit

The Product Quality Assurance Technician ensures Aptissen products meet quality standards and comply with relevant specifications and regulatory requirements.

**KEY TASKS & RESPONSIBILITIES**
- Guarantee the conformity of batch files before release:

- Gather raw production data needed for batch release.
- Gather the analytical raw data needed for batch release.
- Control all raw analytical and production data.
- Ensure that all blocking quality points are closed for batch release (OOS/NC/CC/CAPA).
- Carry out the documentary review of the batch files.
- Write and analyze the annual product quality report.
- Participate in the product validation committee.
- Be the product quality interlocutor with the cross-functional services including contract manufacturing organization.
- Participate in the follow-up of non-conformities linked to manufacturing.
- Write documents related to this daily activity.
- Carry out product quality training for cross-functional departments (production, maintenance, validation, etc.).
- Support for technical complaints. Participate in quality management system related documents (procedures, forms, etc)

**EDUCATION/LANGUAGES**
- BSc in Biology, Biochemistry, Pharmaceutical Science, Pharmaceutical or Chemical Engineering or related field
- Fluency in English.

**PROFESSIONAL SKILLS & EXPERIENCE**
- First experience in the field of Product Quality Assurance, ideally on a medical or pharmaceutical device production site
- Good knowledge of the constraints linked to medical or pharmaceutical device production device
- Experience working in an ISO 13485:2016 manufacturing certified environment
- Excellent computer skills

**PERSONAL SKILLS & COMPETENCIES**
- Good analytical and synthesis skills
- Good planning, communication and presentation skills
- Excellent organizational skills, rigorous
- Creative, Problem solving abilities and Pragmatic
- Strong team player and ability to work across functions

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