大连招聘

The statements below reflect the general responsibilities and requirements of the identified position but may not describe all the work requirements that may be inherent in the job.

I. Job Summary:

An individual in this role verifies compliance to applicable Standard Operating Procedures (SOPs) and regulations (GLP and/or GCP) by performing study protocol, data, report, in-lab phase inspections where applicable, for multiple business lines (e.g., Safety Assessment/Chemistry). Responsibilities include supporting client visits and performing QMS audits without supervision. A Senior GLP/GCP QA Officer leads internal and external facility and supplemental inspections, leads process improvement and harmonization efforts that promote best practices, and prepares and delivers quality and regulatory training. At this level an individual will start to gain experience in assisting with regulatory inspections under supervision.

Duties and Responsibilities:

¨ Performs protocol, data, report, and in-lab phase inspections for multiple business lines to verify conformance to applicable SOP and regulatory requirements.

¨ Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution.

¨ Ensures that systems used in QA are properly maintained (e.g., QA audit records, training records).

¨ Notifies management of service failures.

¨ Manages all aspects of personal, daily micro-scheduling, organization and prioritization related to a full workload.

¨ Performs study sign-off including but not limited to QA statement preparation/review (internal/external) and report finalization.

¨ Performs SOP reviews and initiates or updates SOPs as appropriate

¨ Participates in internal and external facility and supplemental inspections.

¨ Prepares and delivers quality/regulatory training.

¨ Leads process improvement and harmonization efforts that promote best practices.

¨ Support client visits including introductions, data reviews, tours and debriefs without supervision *

¨ Support regulatory visits under supervision *

¨ Supports QMS audits including introductions, data reviews, tours and debriefs without supervision

¨ Performs other related duties as assigned.

(* indicates potential direct client interaction)

Minimum Required:

All candidates would be considered on their own respective merits, but the following is the typical level of experience held by individuals in this position:

¨ At least five years of experience as a quality auditor in a GxP-regulated environment

Minimum Required:

Level of education required (or experience level which may be substituted for level of education).

Professional designations/certifications/licenses required

¨ Bachelor of Science/Arts (BS/BA) degree; degree in a science field is preferred (e.g. chemistry, biology, animal science)

¨ Recognised qualifications to support proficiency in basic numeracy and literacy (precise details will be dependent on the country of location).

¨ Ability to perform basic computer skills (e.g., Word, Excel, PowerPoint)

¨ In exceptional circumstances, directly relevant previous experience may be substituted for degree requirements.

Location: 上海市浦东新区张江伽利略路338号9号楼（班车）

LabCorp是全球顶尖的生命科学公司，科文斯作为LabCorp旗下的药物研发部门，肩负着改善人类健康与生命的共同使命。科文斯的实验室和设施遍布全球，在世界范围内拥有超过26000名员工，卓越的研发能力和强大的人才资源奠定科文斯在医药研发行业的领先地位。截止到2020年，科文斯中国团队共参与了近100个获得上市许可的新药研发，积极支持超过50个免疫肿瘤药物的研发项目，是服务***面的药物研发公司。

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