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Audit and Quality Assurance Services Manager

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 pharmacological client seeks an Audit & Quality Assurance Services Manager to join their team. Role Profile: To line manage the Audit & Compliance Team. To manage GVP audits, reports, audit findings & resulting CAPA management on behalf of client companies. To act as lead auditor on assigned GVP audits. To produce quality & timely audit reports & CAPA plans that are sufficient for inspection purposes. To offer mentorship & support to trainee & contract auditors. To provide Inspection readiness training internally & externally & attend inspections as a company representative as required. To provide procedural GAP analysis to clients & updates to client procedures. To offer vendor management & due diligence support to clients as required. To offer deviation management to clients. To provide clients with Quality Assurance & Auditing expertise. Key Responsibilities: TeamLine management of Audit & Compliance team, including managing team performance, setting performance objectives for team members, conducting regular performance review meetings, & effectively managing holidays & absences. Recruitment of Audit & Compliance team staff, as required. In-house training & organisation of external training courses. Supporting the Head of Auditing & Quality Assurance Services in their duties & being ready to deputise as needed. Procedures. Completing SOP ‘GAP analysis’ on behalf of the company as required by clients. Offering support to clients on the creation & maintenance of procedures in line with GVP requirements. Maintenance of client specific QA procedures as assigned. Responsible for maintenance & update of the core QA procedures (as assigned). Training. The creation of Inspection readiness training & other training material for the company & associated clients. The creation of training material. The delivery of training to clients. The delivery of training to employees. Risk Assessments & Due Diligence. To assist with the preparation of vendor risk assessment forms for the company & for clients. To assist with the interpretation of completed risk assessment forms to determine audit requirements. To assist with the preparation & maintenance of documentation relating to due diligence for vendors. To assist staff with expert knowledge on country specific GVP requirements. Regulatory Intelligence. To keep abreast of global regulatory intelligence required for audit conduct & QA client needs. Vendor Management. To assist the contract management team, as required, with PV agreement creation & maintenance for both the company & associated clients. To conduct vendor selection & management activities as outlined in individual client procedures on behalf of QA clients. Inspections & Audits. The planning, preparation, write-up & performance of independent audits against company standards, SOPs, Good Pharmacovigilance Practice (GVP), quality regulations, local laws & guidelines (Travel required). Maintenance of client audit schedules. Drafting of client audit strategies & maintenance of documents. Maintenance of client PSMFs with client & third party CAPAs. Liaising with clients to ensure all audit requirements & other Quality led requirements are fulfilled to high standards. If you have the required skills please apply online at quoting reference number: 10321.

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