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.
May perform GLP Archivist duties where needed.
Assist in training of new Quality Assurance staff.
All responsibilities are essential job functions unless noted as nonessential (N).
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
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
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.