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Job Details

Senior Clinical Quality Assurance Auditor - 12 months

Company: Hobson Prior
Location: Cambridgeshire
Reference: GCPQAA
Closing Date: 07 Jan 18
Type: Contract
Salary (£): On Application
Benefits: Excellent package!

Job Summary:

My client is looking for an enthusiastic and talented individual who will thrive on challenge and change, and who want to make a difference through the delivery of results.

Requirements:

My client is looking for an enthusiastic and talented individual who will thrive on challenge and change, and who want to make a difference through the delivery of results.

About the Role:

  • To provide objective assurance to my client's management through the preparation, performance, reporting and follow-up of independent clinical quality assurance audits, that clinical trials are conducted in compliance with the relevant GxP guidelines, regulations and my client's or other applicable standard operating procedures (SOPs).
  • To support operational staff through advice and training related to specific area of GxP, regulations and process knowledge and to identify process improvement opportunities through SOP review and audit activities.

Responsibilities:

  • Plan, conduct and follow up investigator site audits (ISAs), supplier, documentation, pharmacovigilance and internal systems audits in accordance with the applicable company SOPs under the direction of the CQA Manager
  • Report and presents to clinical staff, clinical investigators and other hosting company personnel on potential findings identified during the audit
  • Enter CAPAs into the CAPA database and ensures that finding(s) assigned from the CAPA system are closed out in a timely manner
  • Act as a QA specialist providing support to key Clinical Development functions as required
  • Contribute to the development of SOPs
  • Participate in cross functional company GxP audits as required (internal audits, pharmacovigilance audits)
  • Assist with the preparation for and coordination of inspections conducted by international regulatory authorities/external parties
  • Assist with Inspection Readiness activities as required
  • Assist with any other regulatory inspections if requested to do so by the CQA Manager
  • Assist in promotion of quality awareness and quality improvement amongst company personnel and development/maintenance of company GCP and quality standards by means of a training, review, advice and guidance service
  • Liaise with project teams of Pipeline product studies to identify and mitigate risks within the programme and individual studies
  • Attend Pipeline product study team meetings and protocol deviation review meetings to provide support and advice to ensure quality compliance in real time
  • Manage of the Pipeline product audits
  • Write or update CQA SOPs/Guidelines/ Forms/Templates as required
  • Report serious quality issues or non-compliances that are detected whilst carrying out duties for GCP activities to the CQA Manager
  • Mentor CQA staff and consultants as required
  • Assist with GxP/Quality training (including employee induction) as required.
  • Maintain awareness of applicable Regulations and Guidelines and communicate training needs to the CQA Manager 

Requirements:

  • A Bachelor’s degree or equivalent in a science discipline
  • Relevant clinical experience in a healthcare company, with demonstrated knowledge and experience of auditing/inspection techniques
  • Knowledge and experience of working to pharmaceutical regulatory standards in clinical research and
  • knowledge of international regulatory requirements for product registration
  • Knowledge of GCP and GCLP international regulations and guidance with the ability to apply this
  • knowledge to resolve day-to-day issues
  • Excellent interpersonal and communication skills (written and verbal) across a wide range of disciplines, especially the ability to communicate diplomatically and to work efficiently in a multi-disciplinary team
  • Good organizational skills including the ability to work independently or as part of a team, to agreed deadlines
  • Excellent attention to detail and the ability to identify the root cause of problems
  • Assist colleagues as and when required
  • Demonstrate a ‘can do’ approach

 

If this role is of interest please make an application by either completing the form below or you can contact me directly on frankie.cunningham@hobsonprior.com 01892 612 912

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Contact Information:

Address:  Hobson Prior International Ltd
Wellington Gate
7-9 Church Rd.
Tunbridge Wells
kent
TN1 1HT
England
Tel:  01892 612 612
Fax:  01892 612 613
Website:  Visit Our Web Site

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