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Job Details

Principal Quality Assurance Auditor_Permanent Office based _Bangalore

Company: Pharm-Olam International
Location: Bangalore
Reference: PRINCiPAL QA _SS_India _22/11
Closing Date: 22 Dec 16
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

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.

Requirements:

Key Responsibilities

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.
Leadership skills.
Attention to detail.
Require travel and an up-to-date passport.

Apply for this job: Principal Quality Assurance Auditor_Permanent Office based _Bangalore

Contact Information:

Address:  Pharm-Olam International
The Brackens, London Road, Ascot, Berkshire
SL5 8BJ
England
Tel:  +44 (0) 1344 891121
Fax:  +44 (0) 1344 890335
Website:  Visit Our Web Site

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