Compliance & Audit Specialist

PE Global is currently recruiting for a Compliance & Audit Specialist for a leading Pharma client based in Little Island Cork.

Role:

1. Ensure compliance with GMP, GDP, relevant SOPs with suppliers & BluePoint Laboratories Polices & Procedures.
2. Promote the maintenance of a safe, accident free and healthy work environment.
3. Ensure compliance & execute all activities to the BluePoint Laboratories Quality Management System such as non-conformance investigations; deviations; change control, complaints, document control system, record retention & CAPA.
4. Assist in the execution of the internal and external audit programs.
5. Conduct audits of new and existing suppliers to ensure that standards of quality to cGMP & cGDP are being met and such that risks are identified, escalated and can be mitigated and prepare audit reports in the expected time frame.
6. Contribute to audit findings trends and provide recommendations for improvement
7. Follow up on supplier corrective actions to ensure that the agreed appropriate actions are being carried out as committed by the supplier within the expected time frames.
8. Co-ordinate and maintain new and existing Quality & Pharmacovigilance agreements with suppliers. 

Requirements:

1. BSc in a scientific discipline preferred; minimum of five (5) years in a cGMP facility with Production, Quality Assurance or Quality Control experience.
2. The preferred candidate should have completed a Lead Auditor course or equivalent and should have experience in auditing in an international environment.

1. Excellent knowledge of Quality Assurance, GMP, Laboratory Systems and regulatory affairs.
2. Be willing and available for international travel as required (approx. 40%)
3. Be eligible to apply for visas to the following countries: U.S.A., Canada, India, China

Interested candidates should submit an updated CV.

Please click the link below to apply, call Niamh on +353 21 4520313 or alternatively send an up to date CV to Niamh.mcdonald@peglobal.net.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***