苏州招聘

Title/职位: Quality Document Clerk

Department/部门: QS-RA

Location/地点: Suzhou, Jiangsu Province, P.R.China

Reports to (Title)/ 汇报对象(职位): Document Management Leader

§ Perform the principal duties of quality document clerk:
o Responsible for management, issuing and filing of internal and external documents;
o Responsible for control, retention and destruction of quality records;
o Responsible for purchasing and collection of external documents timely;
o Responsible of creating and modification of work instruction related to document control;
o Responsible for coordination of periodical review of documents.
§ Responsible for GMP training:
o Prepare GMP training materials and provide training to each level of employees.
o Responsible for document control training (if needed).
§ Other duties assigned by supervisor according to business requirement:
o Support the review of Device History Record (DHR) or other duties
§ In accordance with DePuy Worldwide Quality strategy, participate to the development of the quality system and its day to day implementation:
o Participate in training or workshop employees and deploy on site the Quality philosophy based on FDA QSRs, ISO 9000 and SFDA requirements.
o Ensures compliance to all GMPs and MDD requirements.
o Conduct internal quality audits as required.
§ Perform all job duties in full accordance with:
o The J&J policies on Information, Assets protection, Maintain password(s) confidential, protect critical Business Information.
o All J&J policies and local regulations.
o The policies of the Health Care and Environmental programs.
o The code of conduct policies.
§ Full responsibility and ownership (like all employees on site) for all audits (internal, Corporate, External, for Quality, H&S, Environment, etc…).



Required Competencies and Skills/所需的能力与技能:

§ Teamwork and communication skill

§ Continuous and versatile learning ability

§ Document management skill

§ GMP knowledge and ISO13485 quality system

§ Computer literacy skill

§ Written and verbal English skill

§ University degree or above

§ 2 years or above working experiences related to document management in medical devices/Pharmaceutical plant

§ Good verbal and written English skill, good PC skill

§ Familiar with GMP, ISO 9001/ 13485 quality system

§ Good teamwork and communication skill

强生（苏州）医疗器材有限公司诚聘