Supplier Compliance Specialist (Pharma, Cork)

CareerWise Recruitment

Cork

COMPLIANCE & AUDIT SPECIALIST with 5+ years in a cGMP facility with Production, Quality Assurance or Quality Control experience, required by CareerWise Recruitment for our multinational generic pharmaceutical client in Cork. The COMPLIANCE & AUDIT SPECIALIST will assist in the organizing and completing of supplier audits for new and existing pharmaceutical finished dosage forms and medical device manufacturing sites, monitoring of suppliers performance, investigation of supplier issues and support the release of finished product. THE ROLE: * Ensure compliance with GMP, GDP, relevant SOPs with suppliers & Polices & Procedures. * Promote the maintenance of a safe, accident free and healthy work environment. * Ensure compliance & execute all activities to the 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. * Maintain familiarity with current regulatory trends, analyze and provide recommendations on how the Quality Standards or Systems should be modified internally & externally. * Support the Freight Forwarder Management Review meetings. * Support the non-conformance & complaint process. * Support the review and communicate the risks associated with warning letters received by suppliers. * Support the Change Control & CAPA processes. * Support the timely receipt and release of finished products. * Provide input to the Quality Management Review process & support the review meetings. * Manage new & existing SOPs for areas of responsibility. * Develop and implements Standard Operating Procedures. REQUIREMENTS: * 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. Please call Conor Twomey today for further information on 021 4297422 or email: ctwomey@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

1109 days ago