Opening in Quintiles for the post of Senior Quality Assurance Auditor

Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics — ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.
Quintiles is consistently cited as the most favored contract research organization (CRO) in independent surveys of the bio pharma industry and was recently named “2009 CRO of the Year” by the prestigious SCRIP Awards.

Post: Senior QA Auditor

Job Description:
Purpose
Plan and conduct independent audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to supervisor, operations staff, management, and customers. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.

Plan, schedule, conduct, report and close audit activities in any of the countries involved with Quintiles contracts. Audits are conducted to assess compliance with applicable regulations/guidelines, customer requirements, Quintiles SOPs and project specific guidelines/instructions.
. Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.
. Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
. Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans.
. Prepare and review and approve corrective action plans
. Present educational programs and provide guidance to operational staff on compliance procedures.
. Conduct quality assurance consultancy activities and projects for clients within budget and established timelines.
. Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
. Host customer audits,
. Assist in hosting mock regulatory inspections and regulatory facility inspections by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as needed.
. Ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections.
. Assist in training of new Quality Assurance staff.

Candidate Profile:
. Bachelor's/primary degree
. 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance; GXP experience;
or equivalent combination of education, training and experience; or equivalent combination of education, training and
experience

Additional Information:
Experience: 5 Years
Location: Mumbai
Education: B.Pharm, M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA, CR
Job Code: 1112700
End Date: 20^th Dec., 2011