Quality Assurance Specialist

Tandem Project Management Ltd.; Carlow; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

Tandem Project Management Ltd. is seeking a QA Specialist to support a biopharmaceutical manufacturing site in Carlow.

The role provides quality oversight across supplier management, new product introduction, quality systems, and site compliance. The successful candidate will review documentation, manage supplier records, support deviations and CAPAs, and participate in cross-functional teams to drive continuous improvement.

Qualifikationen

• Bachelor’s degree or higher in a related science discipline.
• 3–5 years’ quality role experience, ideally in a pharmaceutical manufacturing environment.
• Strong knowledge of Irish, European and international regulatory requirements.
• Working knowledge of cGMP and GDP requirements.
• Experience in supplier quality management, quality systems, equipment or process validation and deviation/CAPA management.
• Experience with sterile filling processes and equipment is an advantage.
• Strong technical writing skills, with experience preparing reports, standards, policies, protocols and quality documentation.
• Proficiency in Microsoft Office and relevant quality or business systems.
• Lean Six Sigma knowledge or experience is an advantage.

Aufgaben

• Provide quality oversight for supplier management activities, including supplier qualification, performance monitoring and periodic re-evaluation.
• Manage Quality Agreements and support the Annual Product Review Quality Agreement chapter.
• Review and approve documentation associated with new product and material introduction, including material packs, QC test specifications, bills of materials and supplier documentation.
• Maintain approved supplier and material records within the relevant supplier management system.
• Support the investigation and closure of deviations and atypical results, including the initiation and follow-up of corrective and preventive actions.
• Support change controls, supplier complaints and material review board activities.
• Author, review and approve protocols and reports for technology transfer, method qualification and method validation.
• Provide quality and compliance guidance in line with site procedures, regulatory requirements and applicable quality standards.
• Assess emerging compliance trends and support continuous improvement initiatives across site quality systems.
• Participate as the QA representative on cross-functional teams supporting new products, materials and site quality initiatives.

Kenntnisse

Quality oversight

GMP knowledge

Regulatory knowledge

Documentation writing

Ausbildung

Bachelor’s degree or higher in related Science

Tools

Quality systems

MS Office

Jobbeschreibung

Summary:

We currently have an opportunity for a QA Specialist to support a biopharmaceutical manufacturing site in Carlow. The successful candidate will provide quality oversight across supplier management, new product and material introduction, quality systems and site compliance activities.

Responsibilities:

• Provide quality oversight for supplier management activities, including supplier qualification, performance monitoring and periodic re-evaluation.


• Manage Quality Agreements and support the Annual Product Review Quality Agreement chapter.


• Review and approve documentation associated with new product and material introduction, including material packs, QC test specifications, bills of materials and supplier documentation.


• Maintain approved supplier and material records within the relevant supplier management system.


• Support the investigation and closure of deviations and atypical results, including the initiation and follow-up of corrective and preventive actions.


• Support change controls, supplier complaints and material review board activities.


• Author, review and approve protocols and reports for technology transfer, method qualification and method validation.


• Provide quality and compliance guidance in line with site procedures, regulatory requirements and applicable quality standards.


• Assess emerging compliance trends and support continuous improvement initiatives across site quality systems.


• Participate as the QA representative on cross-functional teams supporting new products, materials and site quality initiatives.

Qualifications & Experience:

• Bachelor’s degree or higher in a related Science discipline.


• Minimum 3-5 years’ experience in a quality role, ideally within a pharmaceutical manufacturing environment.


• Good knowledge of Irish, European and international regulatory requirements, codes and industry practices.


• Working knowledge of cGMP and GDP requirements.


• Experience in supplier quality management, quality systems, equipment or process validation and deviation/CAPA management.


• Experience with sterile filling processes and equipment is an advantage.


• Strong technical writing skills, with experience preparing reports, standards, policies, protocols and quality documentation.


• Proficiency in Microsoft Office and relevant quality or business systems.


• Lean Six Sigma knowledge or experience is an advantage.