Company: Pharm-Olam International
Reference: PRINCiPAL QA _SS_India _22/11
Closing Date: 22 Dec 16
Type: Full Time
Salary (£): Competitive
Summary: Technically manage a team of SAS programmers, manipulate multiple large SAS data sets, including defining populations and variables, performing calculations and summarizations. Prepare specific analytic deliverables, combining multiple programming outputs to create cohesive reports.
Enhance worldwide clinical quality assurance programmes. To audit ongoing studies, systems and documents to assure quality assurance compliance with regard to ICH/FDA GCP, SOPs, national/local guidelines and the EU Directives, as applicable:
To update Director, Global Quality Assurance/ Senior Management regularly on the level of compliance and compliance issues.
To perform a management role in assisting the Director, Global Quality Assurance, as required.
To recommend corrective actions, improvement in procedures and training requirements
To generate audits plans and reports for Sponsors and management
To promote quality standards and awareness for all Company staff
Provide routine GCP/QA consultation for all Company staff
Ensure the timely and effective follow up of all identified or assigned quality issues
Assist in the review of Pharm-Olam group SOPs
Assist in Sponsor audits/Inspections at sites and at Pharm-Olam offices
Keep up-to-date with relevant guidelines and to assist with internal training, on a regular basis
Routinely assist with the training of more junior auditors
Take on the line management of more junior auditors as required
Deliver on other related duties or responsibilities as assigned by the Director of Quality Assurance
Deputise for the Director of Global Quality Assurance, as required
Assume the management for assigned areas of responsibility within the QA department
Education Requirements and Qualifications
Minimum qualification of a life sciences degree/nursing qualification or appropriate previous work experience (as assessed by the Director of QA).
Minimum experience of 8 years in a GCP environment, with at least 5 years as a CQA Auditor.
A thorough knowledge of ICH GCP and relevant European Directives/FDA guidelines and other national guidelines/regulations.
Excellent communication and interpersonal skills.
Attention to detail.
Require travel and an up-to-date passport.
The Brackens, London Road, Ascot, Berkshire
|Tel:||+44 (0) 1344 891121|
|Fax:||+44 (0) 1344 890335|
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