QA Specialist - CDD 1 year (BBBH480622) Suisse
Kelly Life Sciences is looking for his partner, a pharmaceutical company in the Canton of Geneva, a
Quality Assurance Specialist
CDD – 1 Year
Your Mission
- Ensure GxP compliance for products distributed the client
- Ensure the maintenance of a Supplier Quality Approval process in accordance with GxP and the client QMS
- Ensure a Quality Assurance oversight of contract manufacturing organizations and service providers of the client
- Actively contribute to audits and inspections.
Your Responsibilities
- Gather all the documentation necessary to the release to the market (Switzerland and MENA) of GxP-compliant products by the Swiss QP
- Ensure product quality and compliance (including packaging material) to the regulatory requirements and the proper documentation of all activities
- Manage the internal planning of PQRs for distribution products and review PQRs prepared by QA Portugal
- Manage complaints, deviations and change controls for products distributed by Labatec Pharma (Switzerland + MENA)
- Coordinate product returns and recalls in collaboration with Swiss QP or her delegate
- Bring QA expertise in product launches
- Qualify suppliers in the frame of new products acquisition upon BD initiative
- Ensure there are up-to-date Quality Agreements with all suppliers
- Assess deviations and change controls received from suppliers and follow their impact in collaboration with RA
- Issue and follow complaints to suppliers
- Prepare periodic supplier performance review in collaboration with Supply
- Follow up of CAPAs from suppliers
- Perform transport verification/validation in collaboration with Supply
- Perform a quality follow up of shipments and manage temperature excursions
- Development of Risk Analysis Tools for suppliers
- Development of Risk Analysis Tools for transport and other topics when needed
- Contribute to authority inspection readiness, support local authorities’ inspections
- Write, review, and follow up to approval quality documentation reports, standard procedures and other quality documents
Your Profile
- Degree in a Life Science or Chemistry - PharmD, PhD, MSc
- Excellent spoken and written English and French. German is a plus;
- 3-5 years of relevant quality experience
- Solid knowledge of the GMP and GDP regulations for the pharmaceutical industry,
- Able to work with cross country and cross functional teams
- Ability to communicate to all level of the organization and outside partners
Application:
Please Apply Online, your Kelly contact is Aymeric Shimamungu