Overview
QA Validation Specialist (Packaging) Jobs in Dublin, County Dublin, Ireland at Tandem Project Management Ltd.
Title: QA Validation Specialist (Packaging)
Company: Tandem Project Management Ltd.
Location: Dublin, County Dublin, Ireland
A QA Specialist is required for a biopharmaceutical company in West Dublin. The successful candidate will provide Quality Assurance oversight and support for pharmaceutical packaging operations and packaging-related projects, ensuring packaging processes, equipment, serialisation systems, validation activities, and associated quality systems are implemented and maintained in compliance with cGMP, corporate standards, and regulatory requirements.
Responsibilities:
• Provide Quality Assurance oversight for primary and secondary packaging operations, ensuring compliance with cGMP, regulatory requirements, and company quality standards.
• Provide QA support for new and existing packaging line projects, including installation, commissioning, qualification, and operational readiness activities.
• Review and approve qualification, validation, and verification documentation for packaging equipment, serialization systems, vision systems, labelling equipment, computerized systems, utilities, and associated packaging processes.
• Provide QA oversight for packaging process validation, line clearance, packaging validation, and cleaning validation activities.
• Review and approve project documentation across cross-functional teams including Manufacturing, Packaging Operations, Engineering, Validation, Automation, Technical Services, Supply Chain, Quality Control, and Quality Assurance.
• Provide QA oversight for packaging-related deviations, investigations, non-conformances, and CAPAs, ensuring robust root cause analysis and effective corrective actions.
• Participate in change control activities supporting packaging equipment, packaging components, artwork implementation, serialization systems, and packaging processes.
• Review and approve risk assessments, validation plans, protocols, reports, and supporting documentation associated with packaging equipment, facilities, and operational improvements.
• Provide Quality guidance on validation strategies for packaging equipment qualifications (IQ/OQ/PQ), computerized systems, packaging process validation, and cleaning validation.
• Ensure timely review and approval of GMP documentation, including batch packaging records, SOPs, protocols, reports, specifications, and validation documentation to support production schedules.
• Support supplier qualification activities relating to packaging components, printed materials, labels, cartons, packaging equipment, and contract packaging organisations.
• Perform QA review of packaging procedures, specifications, artwork changes, sampling plans, reconciliation activities, and GMP documentation.
• Ensure packaging equipment qualification, calibration, maintenance, and validation activities are completed in accordance with approved procedures and regulatory expectations.
• Support deviation investigations, root cause analysis, effectiveness checks, and Corrective and Preventive Actions (CAPAs) arising from packaging operations and project activities.
• Provide QA support during regulatory inspections, customer audits, and internal audits relating to packaging operations and associated quality systems.
• Promote inspection readiness and continuous improvement across Packaging Operations and Quality Assurance functions.
Qualifications & Experience:
• Third level qualification (B.Sc. or higher) in Science, Pharmacy, Engineering, or a related discipline.
• Minimum of 6–8 years' Quality Assurance experience within the pharmaceutical or biopharmaceutical industry.
• Strong working knowledge of cGMP requirements, EU GMP Annexes, FDA regulations, and ICH guidelines applicable to pharmaceutical packaging operations.
• Demonstrated experience providing QA oversight for packaging operations, packaging process validation, packaging line qualification (IQ/OQ/PQ), cleaning validation, and packaging equipment lifecycle activities.
• Experience reviewing and approving validation protocols, qualification reports, risk assessments, deviations, change controls, CAPAs, and GMP documentation associated with packaging operations.
• Strong understanding of pharmaceutical packaging processes, line clearance, reconciliation, artwork management, serialization, tamper-evident packaging, and packaging compliance requirements.
• Experience supporting qualification and validation of packaging equipment, vision inspection systems, labelling equipment, serialization systems, and associated computerized systems.
• Experience supporting regulatory inspections involving FDA, HPRA, EMA, MHRA, or other international regulatory agencies.
• Knowledge of quality and manufacturing systems such as Veeva Vault, TrackWise, SAP, DeltaV, MES, or equivalent GMP systems is desirable.
• Excellent technical writing, documentation review, investigation, and problem-solving skills.
• Strong planning, organisational, and stakeholder management skills, with the ability to manage multiple concurrent QA project activities.
• Previous experience supporting packaging operations, engineering, validation, technical services, supplier qualification, warehousing, and quality systems within a GMP-regulated pharmaceutical manufacturing environment is highly desirable.
