QA Drug Substance Operations SpecialistInitial 12 month contract. The QA Drug Substance Operations Specialist will provide on-the-floor Quality Assurance oversight to Drug Substance manufacturing operations. The role supports both technology transfer and commercial manufacturing operations and plays a key part in inspection readiness and continuous improvement initiatives.ResponsibilitiesProvide real-time QA support to Drug Substance technology transfer and commercial manufacturing activities.Perform QA review and approval of SOPs, risk assessments, change controls, deviations, investigations, CAPAs, and other GMP documentation related to Drug Substance operations.Ensure manufacturing activities are executed in accordance with cGMP requirements, approved SOPs, batch manufacturing records, and site procedures.Partner with Manufacturing Operations to ensure deviations, investigations, and batch record reviews are completed and closed within defined timelines.Support timely closure of CAPAs, change controls, self-inspection actions, and other quality commitments related to manufacturing operations.Liaise cross-functionally with Manufacturing, QA, QC, Engineering, MSAT, and other departments to support daily operations.Provide clear communication of quality issues and ensure timely escalation where required.Perform onsite quality monitoring of GMP manufacturing areas.Support internal quality teams to enable on-time disposition of Drug Substance material.Support preparation for regulatory submissions and maintain a state of inspection readiness.Participate in and support health authority inspections, including response preparation and follow-up actions.Identify and drive opportunities for continuous improvement within Quality and Manufacturing Operations.Act as a role model for the QA function and the wider organisation, demonstrating adherence to corporate values and site culture.Demonstrate flexibility to take on additional duties as required by the QA Drug Substance Operations Group Leader.Participate in shift work as required to support manufacturing operations.ExperienceExperience within the biotechnology and/or pharmaceutical industry in a Quality Operations role is preferred.Candidates with backgrounds in Manufacturing Operations, Validation, Engineering, or other technical disciplines will be considered, provided they demonstrate strong knowledge of Quality Management Systems, pharmaceutical regulations, and continuous improvement tools.Strong knowledge of cGxP requirements and regulatory expectations.Demonstrated experience reviewing GMP documentation and supporting manufacturing operations in a regulated environment.Experience with deviation management, investigations, CAPAs, and change control processes.Experience supporting technology transfer activities is desirable.Experience performing internal audits is an advantage.Strong technical aptitude with the ability to interpret complex documentation.Bachelor's degree in a technical discipline (e.g. Biochemistry, Chemistry, Engineering) is advantageous.Strong organisational, communication, and problem-solving skills, with the ability to manage multiple priorities in a fast-paced manufacturing environment.Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organisations throughout Ireland; for more information go to www.berkley-If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact David O'Connell on or send your CV to -