An important role in the QA department, reporting directly to the Head of Quality, the Validation Engineer will be responsible for reviewing and issuing 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 within the Chanelle Group.
KEY RESPONSIBILITIES: Contribute on the preparation and review of the Validation Master Plan – Process and CleaningManage the validation requirements of Chanelle 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)Maintain and take responsibility for the cleaning validation strategy at ChanelleAssume 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 systemLead cross functional teams providing knowledge in resolution in any technical issuesAssist in the preparation and hosting of associated regulatory and customer auditsCOMPETENCIES: Good verbal and written communication skills and the ability to work independently in 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
PHYSICAL DEMANDS: Health & Safety requirements (e.g., Manual Handling Training) Take reasonable care for their own safety, health and welfare at work and that if any other person that may be affected by their actions or omissions while at workCooperate with Chanelle or any of its representatives that will enable the company to comply with the relevant health and safety statutory provisionsAdhere to safety regulations by ensuring correct usage of PPE in laboratory and production areasReport to the supervisor or health and safety representative without unreasonable delay of any defects in plant, equipment, place of work, system or work which might endanger safety, health or welfare of themselves or any employee, contractor or visitor to the companyKeep work area safe, clean and tidyREQUIRED TRAINING: Manual Handling TrainingWorking on PCPERSON SPECIFICATION: B.Sc. / M.Sc. in Scientific Discipline
HPRA / USFDA Experience
Minimum 2 years relative experience in a similar position
Demonstrated ability to work and communicate effectively cross-functionally with all levels of management
Proactive, motivated, analytical and strategic thinker.
Chanelle Pharma
Dublin Road, Loughrea,
Co Galway, Ireland.
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