Company: Advanced Clinical Recruitment Ltd
Location: Central London
Closing Date: 01 Jan 17
Salary (£): Competitive
Benefits: Hourly/Daily Rate
A very well known and exciting Pharmaceutical Company are currently looking for a PV Quality Auditor to join the team, on a contract basis, based in Central London! The ideal candidate for this role will have led Global PV Audits and have experience with FDA and EMA regulations. The company are currently moving through a very promising stage in their progression, so experience picked up in this role will put you in a very good place for further PV QA Opportunities within the industry.
You will be responsible for planning, conducting and reporting R&D QA routine and non-routine audits/assessments and supports inspections of the Pharmaceutical sector worldwide, including Operating Companies (including Consumer for pharmacovigilance), partners and service providers. This may be in a lead role or requiring general supervision depending on the skills and experience of the auditor.
These audits/assessments/inspections provide an independent quality assessment to ensure compliance with appropriate regulations, SOPs, processes, etc. to ensure the quality of company-sponsored R&D and post-marketing pharmacovigilance as well as product quality related activities within the regions (Americas, Europe, Middle East & Africa (EMEA), Asia Pacific). This position primarily focuses on activities and requirements in EMEA.
Leads, plans, conducts and reports R&D QA routine audits/assessments/inspections of activities, data, internal facilities and processes to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. More senior auditors will also lead and/or conduct non-routine audits including Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope.
Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities
May be involved in regulatory inspections in various supporting or lead roles.
Training & Development
Depending on level of expertise, may be involved in the development and provision of training, and may be required to identify training needs. Subject matter experts would be expected to advise and coach other auditors in area of expertise.
Completes training requirements in a timely manner to ensure inspection readiness at all times.
Actively participates in projects and may lead initiatives, as assigned. Interacts with key stakeholders as appropriate. Meets priorities, checkpoints and timelines for all aspects of work and projects to achieve adequate process. May influence and effectively drive projects to completion.
Desired Skills and Experience
Education and Experience:
For further information on how to progress your career through this excellent opportunity, within a fantastic organisation, please contact me ASAP for a completely confidential conversation! Alternatively, to apply directly, please send through an updated copy of your CV, and I will do the rest!
Sam Caley - Advanced Clinical Recruitment
+44 (0) 114 270 1741
LinkedIn Search: Sam Caley Quality Assurance
Keywords: QA, Quality Assurance, GCP, GxP, GMP, GLP, Good Clinical Practice, Auditor, Audit, GCP Audits, Clinical Quality Assurance, Lead Auditor, Head or Quality, Senior Auditor, Senior Manager, Management, Audit Strategy, Structure, Home Based, Field Based, Pharmaceutical, Jobs in Pharma, Pharmaceutics, Generics, Specials, CRO, CQA, GCP Auditor, Manager, GCP Manager, London, Remote, Flexible, Central, PV, PVG, GvP, Compliance
Regus 2nd Floor
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