Hybrid but required to be flexible in this regardNeed experience in sterile or aseptic environment - min 3 years but ideally moreSupervisor – Quality Assurance Team Lead.Duties and Responsibilities:Batch Record Review and material release (includingCoA) 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 andforms from other departments.-Attendance at Daily/Weekly Operations led TeamMeetings.-Responsible for Gemba Walkdowns & InspectionReadiness 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-conformancerecords.-Initiation and ownership of QA non-conformancerecords.-Responsible for periodic review of Quality Assuranceand Quality Systems SOPs.-Primary Quality point of contact for attendance at RootCause 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 flawlessexecution.-Takes personal responsibility for decisions thatsuccessfully build customer value.-Effectively manages and adapts to change.-Always demonstrate Integrity and Credo-based actions.-Ability to work independently, manage their own time andmeet deadlines as appropriate.Education and Experience:-Third level Degree in a science or pharmaceuticaldiscipline.-A minimum of 3 years of experience within thePharmaceutical Industry.-A working knowledge of quality processes and systemsis desirable.-Demonstrated knowledge and application of industryregulations including those of FDA, HPRA, EMEA andother authorities.