Audit & Supplier Qualification Specialist (Maternity Cover)

PCI TRGR Penn Pharmaceutical Services Ltd; Stamullen; Remote; EUR 65,000 - 90,000; Full time

Job summary

PCI TRGR Penn Pharmaceutical Services Ltd in Stamullen, Co. Meath, Ireland, is seeking an Audit and Supplier Qualification Specialist. The role focuses on managing the supplier qualification program, conducting supplier audits, and preparing QTA’s and qualification records.

It requires direct experience in quality systems and cGMP, with exposure to audits for clients and regulators. You will generate SOPs and forms in MasterControl, raise deviations and NCRs, and coordinate multiple tasks while

Qualifications

• Bachelor’s/associate Diploma in Pharmaceutical or life sciences or equivalent.
• 3–5 years’ supplier management and auditing experience preferred.
• Experience with Quality Systems and cGMP regulations is essential.

Responsibilities

• Coordinate on-site Supplier Management Programme, including audits and supplier qualification.
• Raise Deviations, CAPAs, and NCRs and ensure timely communication to QA leadership.
• Ensure activities comply with cGMP and related regulations (ISO 13485 is a plus).
• Generate SOPs, forms, JAs and WI on MasterControl and support audits.
• Host and participate in client and regulatory audits and liaise with staff daily.
• Carry out ad hoc projects to meet department needs and business goals.

Skills

Supplier management

Auditing

Quality systems

Lead auditor

cGMP knowledge

Education

Bachelor/Associate/Diploma in Pharma/Life Sciences

Tools

MasterControl

Job description

PCI TRGR Penn Pharmaceutical Services Ltd in Stamullen, Co. Meath, Ireland, is seeking an Audit and Supplier Qualification Specialist. The role focuses on managing the supplier qualification program, conducting supplier audits, and preparing QTA’s and qualification records.

It requires direct experience in quality systems and cGMP, with exposure to audits for clients and regulators. You will generate SOPs and forms in MasterControl, raise deviations and NCRs, and coordinate multiple tasks while