Welcome page Returning Candidate? Log back in! E-Validation Technician (Long Term Temporary Mission minimum 12 month Contingent ) Job Locations CH-NE-2108 Couvet Job ID 2024-13392 Overview

Job Summary:

 

The Validation Technician, Validation Operation Services performs validation and qualification activities. They assure compliance of these activities with cGMP as well as with internal policies and procedures.

The Validation Technician is authorized to direct external vendors performing work in this field.

Responsibilities

Essential Job Functions:

 

Ensure equipment, systems and processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.Author and when required review qualification and validation documentation, including risk assessments, specification documentation, validation plans, protocols, reports, traceability matrix and summary reportsExecute qualifications for all equipment and systems across the site, including QC, production, warehouse, facilities, equipment, utilities and computer system validation, excluding global IT systems.Execute validations for all processes across the site, including cleaning processes, bulk process, packaging processes and warehouse / sampling processes. Participate to the development and maintenance of the local site proceduresParticipate to risk assessments and risk management teams Review change controls / NEF documents to evaluate impact on qualified systems and validated processesDevelop and justify the validation approach based on risk and a scientific rationalCo-ordinate qualification and validation execution activities, including external vendors and internal departments Qualifications

Experience / Education  

 

BS in Engineering or Technical discipline.Experienced in pharmaceutical qualification and validation; at a solid dosage plant is advantageous

 

Knowledge / Skills / Abilities:

 

Familiarity with current international regulatory regulations, cGxP requirements and best practises, including 21 CFR part 11, 210 and 211, Annex 11n, EU-GMP guidelines and GAMP Good communication skills in English with facility, production, laboratory, technical operations, QA, and outside vendor groups; French advantageousTeam player: ability to interact effectively with team and customers Options Apply for this job onlineApplyShareEmail this job to a friendRefer Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Share on your newsfeed Need help finding the right job? We can recommend jobs specifically for you! An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability Click here to get started.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability
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