Work for Bachelor’s degree in Life Sciences as Senior QA Auditor in Quintiles

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.

Post: Sr QA Auditor-1313110

Job Description
Perform transactional QA activities within the CQA Centralised Services Group, responsible for processing/supporting:
· customer audits and regulatory inspections at investigator sites
· investigator compliance status information
· Quality issue and query escalations to QA

As applicable and/or required:
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.

RESPONSIBILITIES
· Evaluate audit findings/ compliance information 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 in interpretation of audit observations and formulation of corrective action plans.
· Review and approve corrective and preventive action plans
· Oversee documentation, reporting, and closure of complex compliance issues
· Present educational programs and provide guidance to operational staff on compliance procedures.
· Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
· Serve on cross-functional teams, as required
· Develop effective team relationships
· Assist in training of new Quality Assurance staff.
· 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. (N)
· Host customer audits (N)
· 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 (N)

All responsibilities are essential job functions unless noted as nonessential (N)

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REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
· Excellent oral and written English language ability.
· Knowledge of clinical quality assurance processes and procedures.
· Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
· Good knowledge of word-processing, spreadsheet, and database applications.
· Strong interpersonal and oral/written communication skills.
· Excellent problem solving, risk analysis and negotiation skills.
· Effective organization and time management skills.
· Ability to initiate assigned tasks and to work independently.
· Ability to prioritise and multi task.
· Ability to manage multiple projects.
· Ability to establish and maintain effective working relationships with co-workers, managers and clients
· Ability to train and mentor.

Qualifications
* Bachelor’s/primary degree in Life Sciences
* 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance; GCP experience; or equivalent combination of education, training and experience; or equivalent combination of education, training and experience

Additional Information:
Experience: 3-5 year
Qualification: B.Pharm, B.Sc
Functional Area: QA
Job Id: 1313110
Last Date: 9^th Feb., 2014