Quality Auditor

Life Science Recruitment; Tipperary; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

Life Science Recruitment is partnering with a pharmaceutical organisation in Tipperary. The role sits within Global Development Quality (GDQ) and supports GMP Quality Assurance activities for the GDQ IMP Licence at the site.

The candidate will audit data, procedures, facilities and systems, review documentation for release, and participate in CAPA and change control processes to ensure GMP compliance and regulatory adherence.

Qualifikationen

• Degree in an Engineering or Science discipline.
• Significant industrial experience.
• Experience with GMP quality systems and regulatory requirements.

Aufgaben

• Completes audits of data, information, procedures, facilities, equipment and systems to ensure compliance to SOPs, GMPs and applicable regulations.
• Review and approve production and analytical documentation accompanying the release of drug substances and products to ensure conformance to SOPs, GMP and regulatory requirements.
• Communicate and collaborate with cross-functional areas to resolve comments and issues during audit and review.
• Support product recalls and stock recoveries as appropriate.
• Identify compliance gaps and make recommendations for continuous improvement.
• Create and maintain assigned SOPs.
• Perform and review investigations, change controls and CAPAs.

Kenntnisse

Audit experience

GMP knowledge

cGMP compliance

Regulatory understanding

Ausbildung

Degree in Engineering/Science

Jobbeschreibung

We’re currently recruiting for an exciting opportunity with a Pharmaceutical organisation based in Tipperary. This is an excellent position for anyone who is looking to join a leading multinational who are addressing some of the world’s most challenging healthcare needs.

The role is a member of a team within Global Development Quality (GDQ) and is involved in supporting the GMP Quality Assurance activities for the GDQ IMP Licence at the site.

Duties:

• Completes audits of data, information, procedures, facilities, equipment and systems (inc computer systems) to ensure compliance to SOPs, GMPs and applicable regulations.
• Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
• Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilise this network to help resolve comments and issues that arise during audit and review.
• Support product recalls and stock recoveries as appropriate.
• Identify compliance gaps and make recommendations for continuous improvement
• Creates and maintains assigned SOPs.
• Perform and review complaints and deviation investigations, change controls and CAPA’s.
• May assist in the induction process for new starters.
• Generally follows standard procedures and consults with manager/supervisor on exceptions.
• Compiles data for reports and presentations - May interpret data and draw conclusions.
• Carries out all assignments to the standards of compliance, efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements.
• Keep abreast of cGMP requirements as described in applicable worldwide regulations.

Education and Experience:

• Degree in an Engineering or Science discipline.
• Possess significant industrial experience.