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Compliance and Auditing Specialist

Posted on 15 Sep 2021
  • To be advised 
  • Permanent, Full Time
  • Closing in 15 days
  • Search and Select Recruitment Agency
    1 Upper Church St
    IM1 1EE

Our client seeks a Compliance & Auditing Specialist to join their team. Role Profile: To co-ordinate & manage risk assessments & audit programmes on behalf of clients. To review & approve audit reports prepared by independent auditors on behalf of clients. To review & manage Corrective & Preventative Actions (CAPAs) proposed by audited parties through to completion. To prepare & manage due diligence of vendors as part of vendor management. To act as co-auditor/auditor for GvP Audits independently managed by the company. To co-ordinate & manage audits & inspections hosted by the company as directed by line manager. To assist & provide support in the maintenance of the Quality Management System (QMS). Key Responsibilities: Inspections & Audits. To assist in the co-ordination of the preparation for Regulatory Authority inspections of client MAHs. To assist in co-ordinating & hosting internal & external audits including preparation. To assist with the preparation of audit schedules. To assist with the management of Annex G of the client PSMF(s). To assist with any required Internal reviews of the company as required. To communicate with clients & auditors/inspectors with regard to audits & inspections. To work alongside the Pharmacovigilance team, providing clear communication with regard to requirements for upcoming audits/inspections. The review of audit reports, preparation of CAPA response documents & communication with teams for technical input until CAPAs are agreed. To assist with the provision of oversight of upcoming audits to the Technical Executive Board. GvP auditor on behalf of the company. Deviations. To act as back-up to assist in the creation of deviation reporting forms, agreeing root cause. To assist in the tracking & maintenance of internal deviations, both planned & unplanned. CAPAs. Management of external party CAPAs from audit/inspection only. To act as back-up to assist with the logging, creation & management of CAPAs including evidence, closure, QPPV communication. To act as back-up in the creation of relevant impact analysis review form & relevant tracker & forms created. To act as back-up to provide monthly reminders for open deliverables to owners & escalate overdue CAPAs. To provide notification of CAPA status update for the maintenance of the PSMF. External non-compliance. To act as back-up to assist with tracking & management of external non-compliances. To act as back-up to assist with the management & tracking of all external non-compliance. Procedures. To assist in the update & maintenance of QMS procedures, documents, guides & templates as required. To assist in making minor updates to procedures in line with internal CAPAs. To assist with the maintenance of justification documents as requested. Back-up for updates to the SOP Access programme. Quality checks for procedures as assigned. Assistance with PSMF Annex E as requested. Client SOP management as requested. Training. To assist with the creation of training materials as required. Back-up for assistance with staff training & production of training record sheets as requested. Tracking & ensuring the compliant receipt of back to work or new starter training records. If you have the required skills please apply online at quoting reference number: 10322.

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