QA Specialist - CDD 1 year

Posted 08 November 2021
SalaryNegotiable
LocationSwitzerland
Job type Limited
DisciplineLife Sciences
ReferenceBBBH480622_1636370668

Job description

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