Quality Assurance Senior Specialist - Dundalk, County Louth

Job summary

Quality Assurance Senior Specialist responsible for oversight of all validation activities ensuring compliance with current regulatory requirements, cGMP and company SOPs.

Responsibilities

• Ensure the quality oversight of the qualification/validation activities of all facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs) and shipping processes.
• Ensure that all validation documentation and associated data, including but not limited to; plans, URSs, quality risk assessments, protocols, and reports, are reviewed and approved by QA for conformance to SOPs, specifications and other applicable acceptance criteria.
• Ensure that all events/deviations, investigations, and change evaluations that occur during qualification/validation activities have appropriate QA oversight, QA review and approval and adhere to SOPs and cGMP requirements.
• Review SOPs relating to qualification/validation activities.
• Provision of support in Regulatory inspections and Client audits.
• Provision of QA Validations expertise to maintain validation status of the facility.
• Maintain an understanding of cGMP regulations and guidance in relation to all aspects of validation and/or qualification of facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs) and shipping processes.
• Coordinate all QA Validations activities to ensure schedule adherence and on time delivery of project deliverables.
• Manage and develop the QA Validations team including, but not limited to, activities such as performance management, recruitment, and training.
• Other quality activities as needed and assigned.

Qualifications

• B.Sc or B.Eng in a Scientific or Engineering related discipline (e.g. biochemistry, chemistry, engineering).
• Experience in a Quality Engineering/Quality Assurance/Quality Validations role for Biologics or related pharmaceutical/ medical device manufacturing in a FDA/ EU regulated environment.
• Thorough understanding of the validation requirements associated with a cGMP manufacturing facility
• Strong technical aptitude is required.
• Deep knowledge of GxP regulations applicable to biologics manufacturing (e.g. EU-GMP, FDA, ISO) and the industry standards applicable to validation, including but not limited to; GAMP, ISPE, ISO, ASME and BPE.
• Knowledge of trouble shooting and problem-solving skills. Knowledge of formal root cause analysis methods and tools such as Ishikawa diagrams, FMEA etc.

Job description