Quality Assurance Specialist

Beschreibung

Our client, global pharmaceutical company with HQ based in Basel is looking for a quality assurance specialist to manage projects and processes to support departmental projects and objectives according to agreed timelines and standards and assure compliance with GMP guidelines

Major Activities:
1. Performs Investigations of Technical Complaints for clinical supplies and assigns and controls implementation of corresponding CAPAs
2. Manages Deviations, quality events, related actions and CAPAs
3. Contributes to or writes trending reports for Complaints and/or Dashboards
4. Approves GMP relevant documents and decision making according to current SOP for the authority of Quality Project Manager and special authority for GCS (global clinical supply organization)
5. Supports internal audits
6. Provide support to TRD line functions in GMP compliance related issues in area of expertise
7. Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority guidance, SOPs, HSE, etc.). Promote and enforce compliance to guidelines.
Experience requirement:
Good knowledge of cGMP, working knowledge in technical development, production or QA.
Sound scientific, technical and regulatory knowledge.
Prior working experience in production or QA
Education: degree in science or relevant discipline (BSc or equivalent)
Fluent English required (oral & written).

Michael Bailey International is acting as an Employment Business in relation to this vacancy.