Associate Specialist, Quality Assurance
Our Carlow site relies on quality assurance to ensure that our drug product manufacturing process adheres to cGMP and regulatory requirements. As an Associate Specialist in Quality Assurance, you will be responsible for reviewing and approving GMP documentation to support corporate compliance and regulatory expectations for manufacturing operations.
This is a Shift IPT Role, and the shift pattern will be discussed during the interview process, as it may vary at different project stages.
Principal Accountabilities:
Documentation:
- Review and approval of all manufacturing batch documentation, including electronic batch records, real-time reports, and master data, using our site systems.
- Review and approval of SOPs, cleaning verification/validation data, and other documents necessary for the IPT department.
- Drive effective writing, revising, and rolling out of accurate operational procedures, training materials, and maintenance procedures for various Quality-related systems; ensure all work is subsequently carried out in line with same.
- Support the development and implementation of improved quality reporting measures.
- Liaise with Quality Specialists, QP, or QA Lead to resolve queries relating to batch manufacturing processes.
Quality Oversight:
- Work collaboratively to drive a safe and compliant culture in Carlow.
- Work shift patterns in line with manufacturing operations to ensure Quality oversight as required.
- Provide effective real-time on-the-floor support for day-to-day manufacturing operations, such as area clearances, batch record reviews, and aseptic operations.
- Provide quality input into decision-making processes on the shop floor, ensuring product quality is maintained.
- Provide training in all aspects of Quality Management Systems and GMP.
- Ensure all work is carried out in line with SOPs, training, or other quality systems, such as change controls where applicable.
Continuous Improvement:
- Partner with colleagues cross-functionally to provide support and advice on a day-to-day basis and on a project basis, including communications, training, project work, audit/inspection duties, investigations, batch work, customer queries, etc.; thereby ensuring IPT is audit/inspection ready. Conduct area inspections for IPT as appropriate.
- Initiate and maintain Quality-related metrics, ensuring effective communication and follow-up of same. Such ongoing monitoring/metrics gathering may include:
- Monitoring of quality systems,
- The self-inspection program,
- Verification of the effective implementation of key GMP programs
- Effectiveness of Preventative Actions
Key Skills and Knowledge:
- Third-Level Degree qualified in a Science/Technical or related discipline.
- Relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment.
- Knowledge of US and European cGMP guidelines, and other international regulatory requirements, as applicable to the site.
- GMP Audit experience in the pharmaceutical industry
- Problem-solving/critical thinking - ability to understand connections between different technical/quality system areas and recognize potential compliance issues and trends.
- Communication, decision-making, people influencing, and project management skills are important.
- Report, standards, policy writing skills required.
- Demonstrated ability to make and act on decisions while balancing speed, quality, and risk.
- Ability to provide innovative ideas to improve quality and compliance that create value, including seeking new information and external insights.