QA Drug Substance Operations Specialist
Initial 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.
Responsibilities
* Provide 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.
Experience
* Experience 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 -