Quality Assurance Specialist

Aphex Group; Carlow; Vor Ort; EUR 60.000 - 76.000; Vollzeit

Zusammenfassung

Aphex Group in Ireland (Carlow) seeks an experienced Quality Assurance professional to oversee supplier management, documentation, deviations, and compliance for pharma manufacturing. You will drive change controls, CAPAs, and cross-functional collaboration to ensure cGMP/GDP adherence.

The role emphasizes review of material packs, test specs, and supplier qualifications, with responsibility for technology transfer protocols and site-wide quality initiatives.

Qualifikationen

• 3–5 years of experience in a quality role, ideally in pharmaceutical manufacturing.
• Knowledge of regulatory/code requirements related to Irish, European, and international standards.
• Familiarity with cGMP and GDP is preferred.
• Strong report, standards and policy writing skills.
• Experience with equipment and process validation.
• Familiarity with sterile filling processes and equipment is beneficial.
• Proficiency in Microsoft Office and related computer applications.
• Experience or familiarity with Lean Six Sigma methodology is desired.

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 approved supplier management list and ensure correct setup of suppliers and materials used at Carlow
• Support deviation and atypical closeout; initiate and follow up on CAPAs
• Support change controls & Supplier Complaints
• Provide quality oversight for new products/materials and manage external parties with re-evaluations
• Author, review, and approve protocols/reports for technology transfer, method qualification/validation
• Ensure site compliance with divisional policies, regulatory requirements; participate in Plant/Quality committees
• Act as functional expert in cross-functional team for product/material introductions at Carlow

Kenntnisse

Supplier Management

Quality Assurance

Regulatory Knowledge

cGMP

GDP

Documentation Skills

Process Validation

Lean Six Sigma

Team Collaboration

Independent Working

Decision Making

Problem Solving

MS Office

Jobbeschreibung

Responsibilities

• 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.

Requirements

• 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