PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 32 countries and more than 9,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients
Post: Clinical Quality Assurance Auditor
Job Description:
The Clinical Quality Auditor I assesses company activities to assure that contractual obligations to client companies are met, and determines whether clinical trials are conducted and reported in accordance with ICH Guidelines, regulatory requirements, and relevant PPD and client procedural documents.
Performs routine investigator site audits, study file audits, and study document reviews (e.g., Informed consent, CRF, source document templates). Work assignments include multiple therapeutic indications across different projects and clients. Also provides QA consulting advice to assigned PPD project teams, projects and external clients with guidance.
Candidate Profile:
Education and Experience:
Bachelor's degree in a life science field or equivalent qualification and relevant experience
Minimum of 1 year of clinical research experience in regulatory phase trials (e.g. CRA) with high level of competency or
Equivalent combination of education and prior directly related experience
Knowledge, Skills and Abilities:
Successful completion of PPD Foundations Training
Familiar with ICH-Good Clinical Practices and appropriate regional clinical research regulations (e.g., FDA and other regulatory agency guidelines)
Internal candidates must have a thorough working knowledge of PPD Clinical Standard Operating Procedures and Working Practice Documents
Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)
Strong attention to detail
Able to work independently or in a team environment
Good problem solving abilities
Good organizational and time management skills
Basic computer skills and ability to learn and become proficient with appropriate software
Proven flexibility and adaptability
Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for extensive business travel
Additional Information:
Experience: Min. 1 Years
Location: Mumbai
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
Job Code: 105613
End Date: 1st April, 2012
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