Overview
E-Validation Technician/Long Term Temporary Mission Contingent Jobs in Val-de-Travers, Switzerland at WuXi AppTec
Position: Â E-Validation Technician (Long Term Temporary Mission minimum 12 month Contingent )
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.
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 reports
Execute 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 procedures
Participate to risk assessments and risk management teams
Review change controls / NEF documents to evaluate impact on qualified systems and validated processes
Develop and justify the validation approach based on risk and a scientific rational
Co-ordinate qualification and validation execution activities, including external vendors and internal departments
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 advantageous
Team player: ability to interact effectively with team and customers
Title: E-Validation Technician/Long Term Temporary Mission Contingent
Company: WuXi AppTec
Location: Val-de-Travers, Switzerland
Category: Engineering, Quality Assurance – QA/QC
