ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development – from compound selection to Phase I - IV clinical studies
ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.
Post: QA Auditor II/Snr Auditor
Job Description:
Role Responsibility:
Perform QA clinical audits of ICON systems on a regional basis in order to assure compliance with applicable ISO requirements, Good Clinical Practice guidelines, relevant regulations and ICON SOPs.
In addition, your tasks will include:
* Plan and conduct regular and random QA audits of the ICON quality system on a regional basis in order to evaluate the quality system against the requirements of relevant ISO standards, appropriate regulations and applicable guidelines.
* Ensure that audit results and other quality information are formally and consistently recorded and reported and that corrective actions/preventive actions have been requested and are documented effectively.
* Review audit replies to QA. Follow up all outstanding replies and report issues to the relevant management for action.
* Assist in creating summary reports for quality feedback and performance measurement.
* Perform vendor and sub-contractor audits, as well as validation reviews as required.
* Assist with preparation, conduct and follow up of Sponsor and Regulatory audits.
* Assist with ISO registration, surveillance audits and follow up.
Experience and Qualification
* Background in medicine, science or other relevant disciplines.
* Previous relevant experience in QA auditing or equivalent services.
* Proficient in QA procedures and familiar with relevant ISO standards, ICH/ GCP/ GMP and regulatory requirements
* Ability to review and evaluate various types of systems/processes.
* Ability to liaise successfully with departmental and office management.
* Good oral and written communication skills.
* Good interpersonal skills.
* Ability and willingness to travel at least 35% of the time (international and domestic).
* Competent computer skills.
* Fluency in English and local Language
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
ICON Clinical Research is an Equal Opportunity Employer committed to strength in diversity.
Additional Information:
Location: Bangalore
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
Job Code: 9718
End Date: 13th Nov, 2012
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