Overview
Job Summary:
The Validation Technician, 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.
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 advantageous
* Team player: ability to interact effectively with team and customers
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 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
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