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p>For one of our clients, an international pharmaceutical company in the canton of Neuchâtel, we are looking for a
Technicien Specialist QA Validation & QC
Contract: Contractor (long term)
This role offers a unique opportunity to contribute to the quality and compliance of pharmaceutical manufacturing processes within a dynamic and growing organization.
Tasks:
Your responsibilities include, but are not limited to:
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Quality monitoring, deviation follow-up, investigations, management of OOS, CAPA and Change Management.Quality control expertise: OOS, OOT, OOE, method validation/transfer and pharmacopeial surveillance.Review and approval of IT periodic reviews and validation periodic reviews related to computerized and automated systems, as well as data integrity events.Active participation as QA representative in site expansion projects.Review and approval of qualification and validation documentation (DQ, IQ, OQ, PQ, UAT, cleaning validation, process validation).Participation in project management teams for the development and integration of business applications (LIMS, MES, SAP, OSI-PI).Review and approval of data integrity assessments for new and existing systems.Support QC/QA transfers of new products/methods to the Switzerland site.Drafting, reviewing and recommending operating procedures and quality documents.Support for the design of GMBR.Participation in risk assessments and brainstorming sessions on quality issues.Support for QA Operations sales team.Support and supervision of other departments and functions on data integrity issues.Support and supervision of the QC department, identification, and management of QC and GMP compliance issues.Participation in the preparation and support of authority inspections (various roles).
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p>Your profile:
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Min. 3 years' experience in QC and/or QA in a pharmaceutical company or related sector, ideally with experience in computerized systems validation and project management.BSc/BA or MSc in Science or a relevant disciplineThorough understanding of GMP and Swiss, European and FDA regulatory requirements - Knowledge of GAMP a plusIntermediate knowledge of health authority regulations concerning data integrity, data management and Part 11 / Annex 11 compliance.Good understanding of OSD packaging and warehousing, or bulk and QC.Excellent team spirit.Ability to manage multiple projects in a stressful and dynamic environment.Fluency in French and English required