QMS Manager

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von: Kelly Services Switzerland | localité: NeuchâtelN: KellyServicesSwitzerland

QMS Manager

For our partner in pharmaceutical industry, Kelly Life Sciences is looking for a:
QMS Manager
(Temporary position)

Your mission:

  • Supporting the maintenance of the Quality Management System for EMEA/APAC
  • Interface with In-market quality and Global Supply Chain Compliance

Your responsibilities:

  • Prepare, update and/or approve procedures in accordance with GMP/GDP
  • Manage all documents related to procedures and data integrity requirements
  • Act as the Local Process Owner in the execution of QMS activities, compliance initiatives, best practices and industry standards per implementation strategy
  • Monitor deviations, internal and external change controls and CAPA, standalone actions to ensure progression and timely closure
  • Response to internal audits and implementation of corrective actions
  • Review executed forms (destruction, redeployment, etc) and ensure GDP requirements are met
  • Ensure that the quality, safety and traceability of medicinal products are maintained within the supply chain
  • Report any complaints, reported defects, reported falsified medicinal products
  • Lead technical or risk assessment exercises
  • Execute ad-hoc reviews of processes and procedures and provide support in collaborating with Compliance Excellence

Your profil:

  • Bachelor degree in a scientific/ technical discipline
  • Minimum 5 to 8 years' experience in a quality compliance role within the pharmaceutical industry, previous relation to GDP is a plus
  • Formal certified GDP Training on Good Distribution Practice of Medicinal Products for Human Use
  • Up to date knowledge of relevant pharmaceutical legislation and GDP.
  • Demonstrated knowledge and application of industry regulations as they apply to quality, including those of HPRA, EMEA, FDA and other authorities
  • Language: English

Your contact at Kelly:
Manon Tenaud & Anaïs Mieszczak
022 737 12 07 & 022 737 12 05

Site Kelly Services Switzerland