QA Specialist

Morgan McKinley; Carlow; On-site; EUR 45,000 - 65,000; Full time

Job summary

Morgan McKinley in Carlow, Ireland seeks a Quality professional with 3–5 years in a pharmaceutical quality role to oversee supplier management, quality agreements, and documentation for new product introductions. The role involves cross-functional collaboration and ensuring regulatory compliance at the site.

Responsibilities include managing change controls, deviations, CAPA initiation, and supporting validation and technology transfer activities.

Qualifications

• 3–5 years in a quality role, ideally in pharmaceutical manufacturing.
• Regulatory/code requirements knowledge for Irish, European, and international standards.
• Familiarity with cGMP and GDP.
• 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 related computer applications.
• Lean Six Sigma knowledge is desirable.
• Good collaboration and team work abilities.
• Ability to work independently and take ownership of improvements.
• Ability to drive task completion.
• Strong decision-making with accountability.
• Demonstrated problem-solving skills.

Responsibilities

• Supplier Management oversight.
• Quality Agreement management & APR Quality Agreement Chapter owner.
• Review documentation for new product/material introduction (Material Packs, QC Test Specifications, BOMs, Supplier Qualification & Oversight).
• Develop and monitor supplier performance metrics; participate in reviews and cross-functional forums.
• Maintain the approved supplier management list within the qualified Supplier Management system for Carlow.
• Support deviation/atypical closeout and initiate CAPAs.
• Support change controls & Supplier Complaints.
• Provide quality oversight for introduction of new products/materials; manage external parties incl. periodic re-evaluations.
• Author/review/approve protocols and reports for technology transfer, method qualification, and method validation.
• Ensure site compliance by following divisional policies/regulatory requirements; participate in Plant/Quality committees.
• Act as functional expert in cross-functional team for product/material introduction at Carlow.

Skills

Supplier management

Quality oversight

Regulatory knowledge

Documentation & reporting

Cross-functional collaboration

Problem solving

Independent ownership

Decision making

Lean Six Sigma (desirable)

Education

Bachelor's degree in a related Science discipline

Tools

Microsoft Office

Computer applications

Job description

Role Functions

• Supplier Management oversight
• Quality Agreement management & APR Quality Agreement Chapter owner
• 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.
• Support change controls & Supplier Complaints.
• Provide quality oversight and direction for the introduction of new products and materials, as well as manage external parties including periodic re-evaluations.
• Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation.
• 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.
• Participate as a functional expert in the cross-functional team responsible for introducing products and materials at Carlow.

Experience, Knowledge and 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 and Education

• A Bachelor's degree or higher in a related Science discipline is preferred.