Pharma QA & Supplier Quality Oversight Specialist

Morgan McKinley; Carlow; Vor Ort; EUR 45.000 - 65.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Supplier management

Quality oversight

Regulatory knowledge

Documentation & reporting

Cross-functional collaboration

Problem solving

Independent ownership

Decision making

Lean Six Sigma (desirable)

Ausbildung

Bachelor's degree in a related Science discipline

Tools

Microsoft Office

Computer applications

Jobbeschreibung

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.