Cleaning Validation Expert
📋 Détails de l'offre
Our Gi Life Sciences team is actively seeking a Cleaning Validation Expert for a company active in the chemical and pharmaceutical industry.
Mission:
Provide the necessary technical expertise and operational support for equipment cleaning validation activities to ensure GMP compliance, operational readiness and successful regulatory inspections.
Tasks:
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Lead and execute equipment cleaning validation activities, including drafting protocols and reports for COP, CIP, USP, DSP systems as well as buffer preparation and media systems.
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Support and carry out the execution of cleaning validations, notably the COP validation of the parts washer.
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Manage the lifecycle of SOPs related to cleanup validation (creation, review, update, approval).
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Collaborate closely with R&D, Production, QC and Quality Assurance for the development and validation of new cleaning processes or modified processes.
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Ensure the compliant implementation of validated cleaning methods in routine manufacturing operations.
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Act as a technical expert and coordinator in cross-functional projects related to cleaning validation.
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Carry out cleaning validation impact assessments for discrepancies, modifications, and change requests (DR, CR, TCR).
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Actively contribute to customer and regulatory inspections, including the preparation, presentation and justification of validation data.
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Manage customer requests and questions related to the validation aspects of cleaning.
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Ensure consistency and supervision of cleaning validation activities.
Profile :
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Degree in life sciences, biotechnology, chemical engineering or equivalent scientific field.
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Confirmed practice of drafting and reviewing validation protocols, technical reports and standard operating procedures (SOPs) in a GMP environment.
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Proven experience of at least 5 years in validating equipment cleaning, ideally in a GMP environment.
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Excellent understanding of applicable regulatory requirements, including those from FDA and EMA authorities.
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Demonstrated ability to work effectively with MSAT, QA, QC, Manufacturing and R&D teams.
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Structured, rigorous and detail-oriented approach with excellent documentation and data analysis skills.
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Ability to act as a technical expert and coordinate activities in a project environment.
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Fluent in English; knowledge of German an asset.
For any question :
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🏢 À propos de l'entreprise
Entreprise dans le secteur Bâtiment / Immobilier