Maternity-Cover Supplier Audit & Qualification Specialist

PCI Pharma Services; Stamullen; Presencial; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

PCI Pharma Services in Stamullen is seeking a QA professional to manage supplier audits and ensure cGMP compliant operations on site. The role requires a degree in pharmaceutical sciences and 3–5 years of supplier management experience with audits.

Responsibilities include coordinating supplier qualification, CAPAs, NCRs, and hosting client/regulatory audits, while generating SOPs and maintaining MasterControl records. Strong communication and multi-tasking are essential.

Formación

• Bachelor's or associate degree or Diploma / Certificate in Pharmaceutical and/or life science. May substitute experience.
• 3-5 years' supplier management and auditing experience preferred with audits hosting/conducting.
• Experience within Quality Systems and cGMP standards.
• Lead auditor qualifications advantageous.
• Experience in Quality Assurance/Quality Systems/Compliance.
• Ability to follow clear goals and communicate progress to targets.
• Ability to manage multiple tasks and priorities with good interpersonal skills.
• Strong written communication skills.

Responsabilidades

• Ensure safe work practices and regulatory compliance on site.
• Manage supplier audits, qualification, and QTA preparation.
• Raise Deviations, CAPAs, and NCRs and communicate with auditing Manager.
• Ensure activities comply with cGMP and related regulations.
• Generate SOPs, Forms, JA's, and WI's in MasterControl system.
• Support and host Client and Regulatory audits.
• Interact daily with staff and support departments.
• Lead ad hoc projects to meet department needs.
• Carry out additional tasks to support company goals.

Conocimientos

Supplier management

Auditing

Quality systems

cGMP knowledge

Lead auditor

Regulatory knowledge

Communication skills

Written communication

Project management

Educación

Bachelor's degree in Pharmaceutical/Life Science

Diploma / Certificate in Pharmaceutical and/or Life Science

Associate degree in Pharmaceutical/Life Science

Descripción del empleo

PCI Pharma Services in Stamullen is seeking a QA professional to manage supplier audits and ensure cGMP compliant operations on site. The role requires a degree in pharmaceutical sciences and 3–5 years of supplier management experience with audits.

Responsibilities include coordinating supplier qualification, CAPAs, NCRs, and hosting client/regulatory audits, while generating SOPs and maintaining MasterControl records. Strong communication and multi-tasking are essential.