QA Specialist (Senior)

Global Pharmaceutical company, based in Little Island, Cork, IRL - looking for Senior QA Specialist. Duties & Responsibilities:Batch Record Review and material release (including CoA) to ensure compliance with GMP requirements.Quality review and approval of Master Batch Record (MBR) record for routine cleaning and process activities, including Automation recipe updatesQA Review and Approval of SOPs, Work Instructions and forms from other departmentsAttendance at Daily / Weekly Operations led Team MeetingsResponsible for Gemba Walkdowns & Inspection Readiness Walkdowns from a QA perspectiveQA review and approval of Warehouse Shipping PicklistPrimary QA point of contact for Quarantine Shipments.Responsible for Batch Book Filing & Archival.QA review and approval of quality non-conformance (NC) records and customer complaint non-conformance records.Initiation and ownership of QA non-conformance records.Responsible for periodic review of Quality Assurance and Quality Systems SOPs.Primary Quality point of contact for attendance at Root Cause Analysis meetings.Primary QA point of contact for the Returns process.Minimum Requirements / Key Skills and Competencies Required:Builds strong productive relationships.Demonstrates ability to work with teams and individuals.Seeks opportunities to grow and develop professionally.Uses best practices to improve business operations.Holds self-accountable for compliant and flawless execution.Takes personal responsibility for decisions that successfully build customer value.Effectively manages and adapts to change.Always demonstrate Integrity and Credo-based actions.Ability to work independently, manage their own time and meet deadlines as appropriate.Education and Experience:Third level Degree in a science or pharmaceutical discipline.A minimum of 4+ years of experience within the Pharmaceutical Industry.A working knowledge of quality processes and systems is desirable.Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities. The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organizations throughout Ireland, UK & Europe; for more information go to www.berkley-group.comIf you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aleksas Kremenskas at +353 (0) 87 2727949 or send your profile to akremenskas@berkley-group.com