Quality assurance specialist Job in Genève Switzerland

For a great pharmaceutical company, Kelly scientific is looking for a QA Specialist

DESCRIPTION

The Quality assurance Specialist is in charge of the quality-related aspects for the projects and products which are under his/her responsibility. This responsibility starts during the advanced development stage, covers the registration and launch phases, and lasts along the product life-cycle.

As part of the Quality Assurance department, the QA Specialist also actively contributes to the implementation, maintenance and improvement of the Quality Management System (QMS).

The QA Specialist works in close collaboration with internal and external resources and directly reports to the Quality Assurance Manager.

A real partnership exists with the other departments (e.g logistics, development or regulatory staff). External contacts include the clients (affiliated companies, distributors and customers) and the subcontractors (suppliers, contracts manufacturers and external laboratories).

RESPONSIBILITIES

- To review and approve the batch documentation and related quality documents,

- To coordinate the launch of new products, in collaboration with both internal and external partners,

- To qualify the subcontractors (API suppliers, contract manufacturing organisations) and monitor their compliance (by Technical Agreements, regular follow-up and GMP audits),

- To implement quality-related requirements with the subcontractors (e.g. stability studies, PQRs),

- To coordinate the handling of quality issues and related investigations (on complaints, deviations),

- To be involved in the implementation and maintenance of the documentation system (SOPs) and the preparation of inspections and internal audits.

EDUCATION / WORK EXPERIENCE

- Pharmacist or equivalent scientific degree

- At least 3 years of experience in Quality Assurance in a pharmaceutical company

- Previous experience working in close collaboration with subcontractors an advantage

- Previous experience in GMP audits an advantage

QUALIFICATIONS

- Excellent knowledge of applicable European and national regulations,

- Fluent in English and French,

- Well-organised and detail-oriented,

- Strong analytical skills and ability to take decisions,

- Independent with good teamwork and communication skills,

- Keen on working in an international environment within a growing company.

Please, send your application at : mathilde.dromard@kellyservices.ch