Quality , Science, Pharmaceutical & Food
Compliance & Audit Specialist
- Full Time
- County Cork, Cork, Ireland
PE Global is currently recruiting for a Compliance & Audit Specialist for a leading Pharma client based in Little Island Cork.
- Ensure compliance with GMP, GDP, relevant SOPs with suppliers & BluePoint Laboratories Polices & Procedures.
- Promote the maintenance of a safe, accident free and healthy work environment.
- 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.
- Assist in the execution of the internal and external audit programs.
- 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.
- Contribute to audit findings trends and provide recommendations for improvement
- 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.
- Co-ordinate and maintain new and existing Quality & Pharmacovigilance agreements with suppliers.
- BSc in a scientific discipline preferred; minimum of five (5) years in a cGMP facility with Production, Quality Assurance or Quality Control experience.
- The preferred candidate should have completed a Lead Auditor course or equivalent and should have experience in auditing in an international environment.
- Excellent knowledge of Quality Assurance, GMP, Laboratory Systems and regulatory affairs.
- Be willing and available for international travel as required (approx. 40%)
- 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.email@example.com.
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***