Role Function
- Provide QA oversight to support Analytical, Warehouse, and Facilities Management, including deviations, root cause analysis, CAPAs, and change controls.
- Participate as a functional expert in the cross-functional team responsible for introducing products and materials at Carlow.
- Review documentation associated with new product and material introduction, such as Material Packs, QC Test Specifications, BOMs, Supplier Qualification, and Oversight.
- Develop and monitor supplier performance metrics, participate in material review boards and quarterly reviews of key suppliers, and actively engage in cross-functional forums as needed.
- Maintain the approved supplier management list within the qualified Supplier Management system, ensuring correct setup of suppliers and materials used at Carlow.
- Support deviation and atypical closeout, as well as initiate and follow up on corrective and preventive actions.
- Provide quality oversight and direction for the introduction of new products and materials, as well as manage external parties.
- Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation.
- Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
- Serve as the point of contact for quality at both the site level and with external inputs, coordinating and attending Quality working group meetings.
- Facilitate compliance direction for the site by adhering to divisional policies, guidelines, and regulatory requirements. Proactively evaluate site compliance against emerging trends and initiate major compliance initiatives for improved status and operational efficiency. Actively participate in Plant/Quality committees and collaborate with other site functional groups.
Experience, Knowledge & Skills
- A minimum of 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment.
- Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices.
- Familiarity with cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice) is preferred.
- Strong report, standards, and policy writing skills.
- Experience with equipment and process validation.
- Familiarity with sterile filling processes and equipment.
- Proficiency in Microsoft Office and job-related computer applications.
- Experience or familiarity with Lean Six Sigma methodology is desired.
- Good collaboration skills and the ability to work effectively as part of a team to determine priorities.
- Demonstrated ability to work independently and take ownership of improvement initiatives with a moderate level of guidance.
- Proven ability to drive the completion of tasks.
- Strong decision-making capability with a sense of accountability and responsibility.
- Demonstrated problem-solving skills
Qualifications & Education
- A Bachelor's degree or higher in a related Science discipline is preferred.
