Validation Specialist - Skipton, North Yorkshire, United Kingdom - Dechra

Description

SummaryDechra Pharmaceuticals are looking for an experienced Validation Specialist to join our global manufacturing site.

You will be the site Lead for equipment, facility and utility validation to ensure regulatory compliance to established internal and external criteria.

Your duties will also make you responsible for developing the overall validation program within Dechra and providing guidance in establishing and maintaining cGMP compliant processes and site validation master plan.

The role expects you to offer support to the technical, QC and operations teams with validation as required, particularly with implementation of new equipment.

The role will be based onsite at our Skipton location.

Main ResponsibilitiesPrepare, coordinate execution and review protocols and quality risk assessments associated with validation activities to a compliant, cGMP standardSupport the site with validation activities as requiredResponsible for initial and annual requirements such as thermal mapping and heat penetration studies, clean room qualification inc.

non-viable particle counting, warehouse temperature mapping studies & drying oven qualification activitiesDocumentation and remediation of deviations resulting from validation/qualification studiesPrepare and update validation associated SOPsTrouble-shoot and provide recommendation and solution for identified validation and qualification issues based on sound and knowledgeable analysisWork with production and planning to schedule the necessary qualifications/re-qualification's with minimal impact on the manufacturing scheduleRemain current on legislative, regulatory and technical changes within the industryManage the maintenance of the validation equipment in a qualified/calibrated stateRepresent the company at customer and regulatory inspections (including VMD & FDA) and respond to questionsEnsure the Quality Systems metrics associated with Validation are maintained within agreed limits according to the site performance indicatorsTo perform other duties as may be reasonably requested and agreed with Senior ManagementSupport quality and productivity improvementsContribute towards reducing product cost movements through the improvement of production utilisation and ensuring continuous improvementSupport in ensuring department outputs (KPI's) are met and that established cGMP quality standards are adhered to at all timesTake reasonable care of both your own health and safety and that of others who may be affected by your acts or omissions, ensuring all company safety requirements are followed and all relevant legislation complied with, raising concerns and reporting any incidents or suggestions to your line managerEnsure the workplace environment is maintained to a high standard of cleanliness and tidiness, and complies with company and legislative standards at all timesEnsure all waste is disposed of safely and in line with company processes, recycling wherever possible Ideal CandidateExperience of validation and qualification in the Pharmaceutical industryProven industry experience from a highly regulated GMP manufacturing/packing facility, either from the Pharmaceutical or similarly regulated industry/environmentStrong technical writing skills with a thorough understanding of good documentation practiceAbility to prioritize multiple tasks/functions effectively in a global, multi-site organizationWork collaboratively across a matrixed organization in a fast-paced manufacturing environment with the ability to communicate effectively both with the team, and with other areasA working knowledge of continuous improvement activities and ability to manage time and workload effectively is a benefitGood knowledge and understanding of Health & Safety complianceADZN1_UKTJ