Position SummaryThe Product Release & Compliance Quality Assurance (QA) Specialist will play an active role in support of the general site quality system, with a main focus on batch review and product compliance.The QA Specialist will support the ongoing maintenance and continuous improvement of existing QAprocess and Standard Operating Procedures (SOPs) across all disciplines.Position ResponsibilitiesReview & approval of batch records for Cell Culture operations and Purification operations to ensure compliance with the requirements of current Good ManufacturingPractices (cGMP) and batch review and batch disposition process.Partake in QA documentation management, resolve documentation issues that may arise and help produce relevant metrics to monitor efficiency.Support change management, deviations and corrective and preventative action (CAPA) systems as required.Support ongoing review of events, deviations and non-conformances associated with batch release activitiesSupport site risk management proceduresSupport ongoing running and maintenance of Electronic Quality Management SystemProvide QA support to Quality Control including review of Quality Control (QC) raw data.Review and approval of non-conformance reports including deviations, laboratory investigations & environmental excursionsSupport the ongoing site training system and deliver training modules where requiredPartake in the vendor management process to include vendor assessments, auditing and qualification and supplier change notification. Support site Material requirement specifications.Prepare Quality agreements with required Vendors.Partake in Internal and External audit programParticipate in ongoing site data integrity projectsManage specific projects that may arise, in a timely and efficient mannerAssist in supporting the qualification and periodic review of equipmentParticipate in set up of new electronic systems where requiredOverview product and cell bank stability programmes, submission of samples, filing of results and providing updates.Organizational RelationshipsWorking closely with multiple groups for fast-moving projects to ensure proper and timelycommunicationThe role will involve interaction with internal departments QC, Production and Engineering primarily.Resources ManagedFinancial AccountabilityThis position does not have budget accountability.SupervisionThis position does not have direct or indirect reports.Education and ExperienceThird level Degree in a life science discipline.At least 3 years Biotech/Pharmaceutical QA experience with a strong knowledge of cGMP.Good knowledge of regulatory and cGMP guidelines and directives, including product certification, validation, quality control and manufacture including Quality by Design (QbD) and Risk ManagementTechnical Skill RequirementsExperience of interaction with cross-departmental teams.Excellent interpersonal and communication skills, meticulous eye for detail.Self-motivation.Computer literate.Strong time management awareness and the ability to drive projects forward.Physical Position RequirementsRole will be based on site at Zoetis Tullamore site.Physical conditions: lifting light weights (e.g. batch paperwork folders), sitting, standing, walking.Full timeRegularColleagueAny unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.