Duties and 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 updates.QA Review and Approval of SOPs, Work Instructions and forms from other departments.Attendance at Daily/Weekly Operations led Team Meetings.Responsible for Gemba Walkdowns & Inspection Readiness Walkdowns from a QA perspective.QA review and approval of Warehouse Shipping Picklist.Primary 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-conformancerecords.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 RequirementsKey Skills and Competencies RequiredBuilds strong, productive relationshipsDemonstrates ability to work with teams and individualsSeeks opportunities to grow and develop professionallyUses best practices to improve business operationsHolds self-accountable for compliant and flawless executionTakes personal responsibility for decisions that successfully build customer valueEffectively manages and adapts to changeAlways demonstrates integrity and Credo-based actionsAbility to work independently, manage own time, and meet deadlines as appropriateEducation and ExperienceThird-level degree in a science or pharmaceutical disciplineMinimum of 3 years of experience within the pharmaceutical industryWorking knowledge of quality processes and systems (desirable)Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.