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: Senior QA Auditor
* Experience: 2 – 4 Years
* Location: Chennai
* Compensation: Rupees 3,00,000 – 4,50,000
* Perform QA audits of clinical trial data and records in order to assure compliance with ICON or Sponsor SOPs, study protocols, Good Clinical Practice guidelines, relevant regulations and ISO 9000 requirements.
* In addition, your tasks will include:
* Be knowledgeable with all relevant ICON SOPs, ISO 9000 requirements and appropriate regulations and guidelines.
* Effectively plan and conduct regular and random QA audits (internal and external) in order to assure that clinical studies managed by ICON are of the highest standard and are in compliance with the requirements of ICON or Sponsor SOPs, study protocols, relevant regulations and guidelines and with ISO 9000 requirements.
* Perform quality system audits if required.
* Perform contract audits for Sponsor companies as required.
* Ensure that audit results are formally recorded and reported and that corrective/preventive actions are documented.
# When appointed lead auditor, perform the duties assigned in an efficient and effective manner. This includes liaison with the project manager on all QA issues, including audit planning and review of audit results.
# Assist with the development of the project audit procedures.
# Assist in training new QA auditors.
# Assist in training ICON staff regarding GCP, ISO 9000, role of QA, regulatory inspections etc.
# Conduct induction/orientation of new staff in ICON quality policies and procedures.
Experience and Qualification
* Background in medicine, science and/or other relevant discipline and appropriate experience.
* Previous experience in Quality Assurance auditing.
* Detailed knowledge of GCP guidelines and relevant regulations for the conduct of clinical trials.
* Ability to review and evaluate clinical data / records.
* Excellent communication and interpersonal skills.
* Ability to successfully implement quality plans for specific phases of a trial.
* Ability to liaise successfully with project teams.
* Good understanding of drug development and clinical trial process.
* Good planning and organizational skills.
* Competent computer skills.
* Ability and willingness to travel at least 35% of the time (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.
* ICON Clinical Research is an Equal Opportunity Employer committed to strength in diversity.
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.
Interested & Eligible candidates can send their resume to eval(unescape('%64%6f%63%75%6d%65%6e%74%2e%77%72%69%74%65%28%27%3c%61%20%68%72%65%66%3d%22%6d%61%69%6c%74%6f%3a%6d%61%6c%61%72%6b%61%6e%6e%61%6e%2e%6a%40%69%63%6f%6e%70%6c%63%2e%63%6f%6d%22%3e%6d%61%6c%61%72%6b%61%6e%6e%61%6e%2e%6a%40%69%63%6f%6e%70%6c%63%2e%63%6f%6d%3c%2f%61%3e%27%29%3b')) with ref id: QA-5178
Saturday, November 27, 2010