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Job Details

Senior Clinical Quality Assurance Executive

Company: Hobson Prior
Location: Cambridgeshire
Reference: SQAE
Closing Date: 09 Dec 17
Type: Contract
Salary (£): On Application
Benefits: Dependent on Experience

Job Summary:

To provide objective assurance to our 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 our client or other applicable standard operating procedures (SOPs).

Requirements:

Senior Clinical Quality Assurance Executive

About the Role:

To provide objective assurance to our 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 our client 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.

To support QA and operational staff in the preparation for, and during competent regulatory inspections through on-site visits to investigator sites and/or vendor sites and/or review of Trial Master Files (TMFs).

Responsibilities:

 

To act as QA Operational Lead on assigned studies.

To assist the QA Manager with the implementation and conduct of the QA audit programme as assigned.

To report audit findings to the QA Manager and the client groups in accordance with company SOPs.

To assess the appropriateness and monitor the implementation of corrective and preventative actions (CAPA) arising from audits and track to satisfactory closure.

To assist with the preparation for inspection readiness and hosting of regulatory inspections and external party audits.

To assist with the preparation for clinical investigator inspections conducted by national and international regulatory authorities and other external bodies such as marketing partners. 

To assist the QA Manager with the promotion of quality awareness among company personnel and assist with the development and maintenance of company GxPs and quality standards by means of a training, review, and advice and guidance service.

To identify and communicate quality improvements in GxP activities.

To provide day to day support, mentoring and training to other members of QA and QA consultants via the production and implementation of training programmes and assessing competency where appropriate.

Requirements:

A Bachelor’s degree or equivalent in a scientific discipline.

Strong relevant experience and high level of competency for the planning, conduct, reporting and follow-up of audits within a clinical research environment working in a Pharmaceutical or other regulated industry.

Thorough knowledge of GCP international regulations and guidance, (including UK, European, United States) with the ability to apply this knowledge to resolve day-to-day issues.

Understanding of the Quality Management System requirements to support compliance to GCP.

Excellent attention to detail and the ability to thoroughly investigate issues and identify the root cause of problems.

Excellent interpersonal and communication skills (written and verbal).

Good organizational skills, including the ability to work independently or as part of a team, to agreed deadlines.

 

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

OR

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Apply for this job: Senior Clinical Quality Assurance Executive

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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