Our client, a world-wide pharmaceutical industry specialized in the synthesis of active pharmaceutical ingredients is looking for a
Quality Assurance Manager
Location: Neuchatel area, Switzerland
Contract: permanent
Start date: asap
Tasks
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Support the implementation and execution of the Quality Management Review process and to ensure compliance with ISO 9001 as well as local regulatory requirements.
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Conduct of inspections / audits with Authorities (FDA, EMEA) and clients
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Management of internal and external audits (suppliers)
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Assessment and follow-up of complaints, deviations, Change Control, OOS, CAPA
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Drafting of protocols and validation and qualification reports, Site Master File, GMP Training, Annual Management Review, Product Quality Review (PQR)
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Writing, modifying, reviewing and distributing the procedures (SOP) of the whole company
Requirements:
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Master’s degree in Life Sciences, preferible Chemistry.
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At least 3-5 years of in quality assurance within a GxP industrial environment such as Pharmaceuticals, Medical Devices, Biotech.
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Excellent working knowledge/understanding of ISO and International Conference on Harmonization (ICH) Q8, Q9, Q10 requirements.
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In-depth knowledge of current standards in the pharmaceutical (CGMP, ICH, USA CFR, GDP).
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Knowledge in Regulatory affairs is an additional asset.
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Fluent in both written / spoken French and English (proficiency in Italian would be an asset)
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Strong customer focus, communication, presentation and interpersonal skills, to ensure cross-functional collaboration.
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Self-motivated, result-oriented, proactive, purposeful, efficient and enthusiastic.
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Fluent in both written / spoken English (proficiency in French would be an asset).
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Flexible and can travel internationally up to 50% would be ideal.
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Experience in conducting audits and in working on audit report submission and follow up would be preferred.
We are looking forward to receiving within your application:
- your CV in English
- latest Work Certificates
- your Motivation Letter
- ID/passport copy
Apply now to be considered – Good to know you!
For more information and your application, please contact: Barbara Sorce, Team Leader Life Science Professionals, M +41 79 376 00, barbara.sorce@ch.randstad.com