An important role in the QA department, reporting directly to the Associate Director of Quality, the Validation Manager will be responsible for oversight and management of the site Process and Cleaning validation function 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.
ESSENTIAL DUTIES AND RESPONSIBILITIES: Contribute on the preparation and review of the Validation Master Plan – Process and CleaningContribute to the management of 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)To maintain and take responsibility for the cleaning validation strategy at ChanelleContribute to the management and responsibility of 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 appropriateIdentifying training requirements in support of validation DepartmentEnsuring completion of validation protocolsCarry out Internal Audits as requiredResponsible for the execution of Risk Assessments or Investigation reports relative to the rolePublish Monthly Validation Metrics on KPIRequired to Lead cross functional teams providing knowledge in resolution in any technical issuesAssisting 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; environment
? Good computer skills with Word, Excel and any other statistical programs
? Knowledge of Process and Cleaning Validation
? Ability to conduct internal audits
? Ability to perform in external audits
QUALIFICATIONS: Minimum Bachelor of Science or Engineering
PHYSICAL DEMANDS: Health & Safety requirements (eg. Manual Handling Training)
To take reasonable care for their own safety, health and welfare at work and that if aby other person that may be affected by their actions or omissions while at workTo cooperate with Chanelle or any of its representatives that will enable the company to comply with the relevant health and safety statutory provisionsAdheres to safety regulations by ensuring correct usage of PPE in laboratory and production areasReports 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 companyKeeps work area safe, clean and tidyRequired Trainingo Working on PC
PERSON SPECIFICATION: B.Sc. / M.Sc. in Scientific Discipline
Minimum 2 years relative experience in a similar position
Demonstrated ability to work and communicate effectively cross-functionally with at all levels of management
Proactive, motivated, analytical and strategic thinker.
WORK ENVIRONMENT: (eg. Office, Production)
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5 R&D
Labs3000+ Animal
Health Licenses100
countries4 Manufacturing
Facilities550
employees1200+ Human
Health LicencesCustomer Always Comes FirstChanelle Pharma
Dublin Road, Loughrea,
Co Galway, Ireland.
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