OM Pharma O

Validation Expert (BB-D2F6B)

Gefunden in: Xpatjobs CH

Beschreibung:

About You

In view of our continued global growth we are expanding our production capacities. For this reason we are looking for further support and recruiting our new Validation Expert at our biotech production site in Meyrin/Geneva. In this position you take care of the manufacturing and cleaning processes validations. Reporting to the Head of Validation & Process Engineering your main missions are as follows: Perform or finalize gaps assessment and compliance check in the field of Manufacturing and Cleaning Process Validations Establish in close collaboration with the Head of Validation and Process Engineering the corresponding remediation plans Lead risk analyses in close collaboration with Manufacturing, QA, QC and P&ID teams and establish related validation strategies Establish strategies for process and cleaning validations and continuous cleaning and process verification Execute validation activities according to remediation plan: process and cleaning validation including for manual cleanings, periodical validations, DHT/CHT validations, Write and review validation protocols, raw data, reports and SOPs of the unit in compliance with GMP Define, monitor, implement and close CAPA and change control (risk analysis, action plan, action owner ) in collaboration with the various departments involved. Manage deviations issued as part of validation activities Write and review SOPs related to the defined fieldsTo carry out these tasks the ideal candidate will have an Engineering/Master degree in a closely related area in addition to the following: You bring at least 15 years of experience in validation/qualification in FDA approved pharmaceutical or biotechnology industries Strong and proven knowledge and experience in GMP biotech manufacturing site Very good interpersonal skills with excellent listening and communication skills Cross-functional and transversal management skills Full fluency in French and very good written knowledge of English are a mustYou are a rigorous person and autonomous in your work.Endowed with an entrepreneurial spirit, you know how to manage different cross functional stakeholders.You like to take a step back to analyze situations and propose new strategies.You define yourself as a solution-oriented and methodical person who drives novelty.Thanks to your communication skills and strong team spirit, you integrate quickly into a new environment and easily establish collaborative links with other departments.If this sounds like you please do apply to this new position with us at OM Pharma in Meyrin/Geneva.

calendar_todayvor 15 Stunden

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location_on Meyrin , Geneva, Schweiz

work OM Pharma

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