Role This position within the QA department provides Quality support and knowledge to activities relating to Quality to meet business priorities. The QA Specialist promotes Quality across cross functional teams, to deliver high quality products, ensuring continuous process improvement. The QA Specialist models the behaviours and understands the principles to drive a culture of continuous improvement building a High-Performance Organisation Key Responsibilities Monitor packaging operations and activities within the QA Group to ensure compliance with GMP, SOPs and company quality standards Perform Acceptable Quality Level Inspections on the Packaging Line to verify that Finished Products and Components meet predefined quality criteria. Performs QA Release of packaging components by reviewing supplier documentation, verifying compliance with specifications, and ensuring components are fit for use in production. Maintain traceability and accurate records for all released materials. Generate and manage Packaging-related paperwork to such as e.g. CCFPs, Barcode Issuance Forms Compilation of Lot Release Packs as per requirements of SOPs, WIs and related FRMs. Maintain an organised archiving system for batch records and GMP documentation. Ensure timely filing and retrieval of records to support audits, inspections and internal reviews Participate in root-cause analysis and drive corrective and preventative actions Assist in investigating customer complaints related to packaging defects or discrepancies. Gather data, analyse findings and support resolution efforts to maintain product quality and patient safety Compile and input data for key team performance metrics and and provide accurate reports to support continuous improvement initiatives Prioritize tasks to ensure the critical tasks are completed on time and meet requirements. Write, review and approve Standard Operating Procedures in accordance with the companies Policies. Plan, coordinate and implement packaging related projects within defined objectives and timelines. Collaborate with cross functional teams to achieve project goals and deliverables. Other duties assigned. Qualifications & Experience Required Degree or 3rd level qualification (Science, Quality). Relevant experience (1yrs +) working in a Quality function in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the other requirements of the role. Demonstrates good knowledge of FDA / EMEA regulations/standards and quality systems. Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance. Demonstrated ability to work and succeed within teams as well as leading small project teams while maintaining and strengthening trust relationships with people on all levels. Strong organizational skills, including ability to follow assignments through to completion. Proficiency in PC skills such as Excel, Word, PowerPoint. Excellent written and verbal communication skills. Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non-Conformance /Deviation investigations. Desired Experience in preparing lot release files Experience in execution, documentation and follow-up of in-process inspections for Secondary Packaging processes. Evidence of Continuous Professional Development. ERP Experience Good knowledge of Lean / Continuous Improvement practices and root cause analysis. Behaviours Always focused on the patient and customer needs. Curious with learning agility. Operationally excellent, with attention to detail. Organised with systematic approach to prioritisation. Process orientated to achieve the business objective Skills: ERP Packaging Supplier Documentation SOP FDA