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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
