GMP Compliance Engineer - Sterile Manufacturing

Aphex Group; Carlow; In loco; EUR 42.000 - 65.000; Tempo pieno

Descrizione del lavoro

Aphex Group in Carlow is seeking an Engineering Compliance Specialist to support GMP and sterile manufacturing operations. The role focuses on review of deviation reports, CAPAs and engineering change controls to ensure timely documentation and regulatory compliance.

You will collaborate with IPT, Quality, EHS and other departments to uphold compliance, while following cGMP and global policies in daily tasks. Strong communication and relevant regulatory knowledge are essential.

Competenze

• Diploma or higher in a related discipline preferred.
• Prior GMP manufacturing experience is advantageous.
• Excellent written and verbal communication with cross-functional teams.
• Familiarity with Irish, European and international regulatory expectations.

Mansioni

• Direct and/lead deviations, out of tolerance conditions and unexpected results, conducting failure analysis and implementing CAPAs.
• Supporting Engineering documentation review - e.g. electronic logs
• Supporting Audit Readiness activities.
• Supporting Internal Audit programs
• Collaborate with Engineering colleagues and other departments to maintain compliance
• Adhere to global policies, procedures and cGMP in daily activities.

Conoscenze

GMP experience

Diploma/degree

Communication skills

Regulatory knowledge

Sterile filling experience

MS Office proficiency

Formazione

Diploma or higher in related discipline

Strumenti

Microsoft Office

Descrizione del lavoro

Aphex Group in Carlow is seeking an Engineering Compliance Specialist to support GMP and sterile manufacturing operations. The role focuses on review of deviation reports, CAPAs and engineering change controls to ensure timely documentation and regulatory compliance.

You will collaborate with IPT, Quality, EHS and other departments to uphold compliance, while following cGMP and global policies in daily tasks. Strong communication and relevant regulatory knowledge are essential.