Work at Quintiles as Senior QA Auditor - Clinical

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 - Clinical

Job Description:
Global responsibility for managing the delivery of GCP QA services for the Therapeutic Delivery Units as directed by the Global Therapeutic QA Leads. Plan and conduct independent audits to assess compliance with regulations, guidelines, and operating procedures. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.

RESPONSIBILITIES
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. Audits may include but are not limited to: investigator site audits, process audits, office audits and telephone audits.
Conduct Quality Planning Team meetings and review and approve resulting risk mitigation plans for projects
Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
Write audit plans and assure proper entry of required audits into QA systems
Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans.
Prepare, review and approve corrective action plans

Present educational programs and provide guidance to operational staff on compliance procedures.
Facilitate preparation for customer audits and host customer audits as delegated by the Global QA Lead
Assist in hosting mock regulatory inspections and regulatory inspections of Quintiles facilities by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as needed.
Assist the Global QA Leads in management of Quality Issues
Assist in training of new Quality Assurance staff.

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Candidate Profile:
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Knowledge of word-processing, spreadsheet, and database applications.
Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
Knowledge of quality assurance processes and procedures.
Strong interpersonal skills.
Excellent problem solving, risk analysis and negotiation skills.
Strong training capabilities.
Effective organization, communication, and team orientation skills.
Ability to initiate assigned tasks and to work independently.
Ability to manage multiple projects.
Ability to establish and maintain effective working relationships with coworkers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's/primary degree
5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance; GCP experience; or equivalent

PHYSICAL REQUIREMENTS
Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time
Position requires extensive use of telephone and face-to-face communications, which requires the accurate perception of speech
Travel required, may include international travel.

Additional Information:
Experience: 5 Years
Location: Bangalore, Mumbai
Education: B.Pharm, M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA, CR
Job Code: 1104041
End Date: 7^th Oct., 2011