昆皓睿诚医药研发(北京)有限公司

北京 ·制药(生物/化学) ·100-499人

Senior QA Auditor

10000-15000

北京

3-5年

不限

全职

职位描述
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).

任职要求:



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.



工作地址
北京市大兴区经济技术开发区凉水河二街8号大族企业湾15号楼1-3层
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