Jobs, fresher vacancy - IRL - QA Specialist - Senior • Derrygonnelly

Company: Lancesoft Europe

Derrygonnelly

Description: Hybrid but required to be flexible in this regard Need experience in sterile or aseptic environment - min 3 years but ideally more Supervisor Quality Assurance Team Lead. 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-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 3 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. Enable Skills-Based Hiring No Actual End Date try { var fgTooltip = new FG.Tooltip({ element: $('#cf_descz20042714312056838244905'), text: "Enter\x20actual\x20intended\x20end\x20date" }).initialize(); } catch(err) {} Additional Details Pool : (No Value)Actual End Date : 2026-11-01Job Function : QualityJob Subfunction : Quality AssuranceEquivalent Permanent Annual Salary : 0.00