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Tuesday, October 18, 2011

ICON Clinical Research looking for Quality Assurance Auditor


Job Description:By performing QA audits of clinical trial data, records and ICON systems; you will assure compliance with ICON or Sponsor SOPs, study protocols, Good Clinical Practice guidelines, relevant regulations and ISO 9000 requirements. Depending on your level of experience, you will also be involved in project audit management, staff training and contribute to the review of ICON systems and procedures as appropriate.• A wealth of knowledge of all relevant ICON SOPs, ISO 9000 requirements and appropriate regulations and guidelines will enable you to effectively plan and conduct regular and random QA audits. You will ensure that clinical studies managed by ICON are of the highest standard and in compliance with the requirements of ICON or Sponsor SOPs, study protocols, relevant regulations and guidelines and with ISO 9000 requirements. You will also perform quality system audits and contract audits for Sponsor companies if and when required.
• Assisting in a number of key areas, you will help with the development of project audit procedures, mentor and train new QA Auditors and assist in the training of ICON staff regarding GCP, ISO 9000, the role of QA, regulatory inspections etc. You will also support business development activities and the co-ordination of Sponsor and Regulatory audits as appropriate.
• Assuming additional QA responsibilities or assisting with the management of the department (depending upon your level of experience); you will be required to advise the person to whom the Senior QA Auditor reports of any QA issues within the department that require attention.
Candidate Profile:• With a background in medicine, science and/or other relevant discipline you should have previous experience in Quality Assurance auditing.
• Competent computer skills and a thorough understanding of drug development and clinical trial process, along with detailed knowledge of GCP guidelines and relevant regulations for the conduct of clinical trials, will enable you to review and evaluate clinical data/records.
• Highly organised, you will have the ability to multi-task and prioritise effectively. You will also possess excellent communication and interpersonal skills, and the ability to coach and mentor, in order to liaise successfully with project teams and implement quality plans for specific phases of a trial.
• You must be willing and able to travel at least 35% of the time (both international and domestic).
• You will have the opportunity to progress your career and may wish to move into Project Management or into other related areas where you can further develop your skill set.
• Come to ICON and be an important part of a well respected and growing company that believes the details of your career are every bit as critical as the work you do. You'll enjoy highly competitive compensation and an exceptional benefits package.

Additional Information:
Experience: 2-7 Years
Location
: Bangalore
Education: B.Pharm, M.Pharm, B.Sc, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 17th Nov., 2011
Mail your resume to, malarkannan.j@iconplc.com

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