长沙招聘

职位描述：

Location: Beijing (preferred) or Shanghai

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.

● 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

● 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

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.

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QuintilesIMS pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster.
 
If that is your passion, we have a place for you.