Pharma Quality Auditor - GMP Compliance (11-month Contract)

PE Global; Tipperary; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

PE Global is seeking a Quality Auditor for a leading pharmaceutical company in Tipperary, Ireland. The role is an initial 11-month contract within Global Development Quality, focusing on GMP QA activities.

Responsibilities include auditing data and documents for release, supporting recalls, and driving continuous improvement. The ideal candidate has a engineering/science/quality degree and 4+ years in FDA/EMEA regulated QA.

Qualifikationen

• 4+ years of QA auditing experience in FDA/EMEA environments.
• Degree in Engineering, Science, Quality, or related field.
• Strong written and verbal communication skills.
• Ability to work independently and in a team.

Aufgaben

• Audit data, information, procedures, facilities, equipment and systems to ensure GMP compliance.
• Review and approve production and analytical docs for release and QP certification.
• Collaborate with cross-functional teams to resolve audit findings and issues.
• Support product recalls and stock recoveries as needed.
• Identify compliance gaps and propose continuous improvement.
• Create and maintain SOPs.
• Perform investigations and change controls.
• Assist in onboarding new starters.
• Prepare data for reports and presentations.
• Keep up with cGMP requirements.

Kenntnisse

Audit experience

GMP knowledge

Regulatory compliance

Communication skills

Analytical thinking

Ausbildung

Engineering/Science/Quality degree

Jobbeschreibung

PE Global is seeking a Quality Auditor for a leading pharmaceutical company in Tipperary, Ireland. The role is an initial 11-month contract within Global Development Quality, focusing on GMP QA activities.

Responsibilities include auditing data and documents for release, supporting recalls, and driving continuous improvement. The ideal candidate has a engineering/science/quality degree and 4+ years in FDA/EMEA regulated QA.