Overview: An important role in the QA department, reporting directly to the Head of Quality, the Validation Engineer will be responsible for reviewing and issuing of validation protocols and reports and also the co-ordination of the execution of validation activities (process / cleaning and equipment and computer qualifications) with the relevant departments
KEY RESPONSIBILITIES: Contribute on the preparation and review of the Validation Master Plan – Process and CleaningManage the validation requirements and third party suppliers and CMO'sManage the preparation, review and issuing of Validation Protocols and Reports (this to include equipment, cleaning, process and computer system validation)To maintain and take responsibility for the cleaning validation strategy To assume responsibility for the cleaning validation master plan confirming to accepted practices and demands of the competent authorities in the EUImplementation of Process Validation of new products for regulatory submissions ensuring compliance to proposed registered specificationsCoordination of the execution of Validation in accordance with protocols by Production, Quality Control and R&D teamsEstablishing, implementing and directing validation and revalidation activitiesLiaise with contract manufacture customers in seeking their approval for protocols and reports where appropriateReviewing and managing Change Control Forms for Validation implicationsReviewing and managing Non-Conformances for Validation ImplicationsUpdating existing quality documentation related to validation activitiesIdentifying training requirements in support of validationEnsuring completion of validation protocolsCarry out Internal Audits as requiredResponsible for the execution of Risk Assessments or Investigation reports relative to the roleMaintaining validation documentation systemRequired to Lead cross functional teams providing knowledge in resolution in any technical issuesAssisting in the preparation and hosting of associated regulatory and customer auditsCOMPETENCIES: B.Sc. / M.Sc. in Scientific DisciplineHPRA / USFDA ExperienceMinimum 2 years relative experience in a similar positionDemonstrated ability to work and communicate effectively cross-functionally with at all levels of managementProactive, motivated, analytical and strategic thinker.Good verbal and written communication skills and the ability to work independently in an analytical environmentGood computer skills with Word, Excel and any other statistical programsKnowledge of Process and Cleaning ValidationAbility to conduct internal auditsAbility to perform in external auditsQUALIFICATIONS: Minimum Bachelor of Science or Engineering
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