东莞招聘

要 求：
M.Sc. or Bachelor degree (or equivalent combination of education and experience) in synthetic organic chemistry, analytical chemistry, or other related fields, with a minimum of five 5 years of relevant experience working in cGMP facilities engaged in the manufacture and/or quality control/assurance of bulk active pharmaceutical ingredients (APIs), excipients, and/or dietary ingredients and their finished dosage forms.
Should have extensive knowledge of FDA regulations pertaining to cGMP requirements, ISO 9001 and ISO 17025. A certificate from the American Society for Quality (ASQ) as a Certified Quality Auditor (CQA) is desirable. Working knowledge with International Conference on Harmonization (ICH) quality guidelines, and multidisciplinary guideline on the Common Technical Document (CTD) format for APIs, is desirable. Should be proficient with regulation and guideline interpretation, audit procedures, proper documentation, and QA and departmental policies and procedures. Industry experience in the establishment of quality systems compliance is preferred. Knowledge of and experience with analytical methodologies is desirable. Should have good organizational and planning skills; and excellent verbal and written communication skills (English and Chinese). Should be detail oriented; able to deal with multiple changing priorities; and able to work with minimal supervision. Effective and efficient project management experience and CMC submission experience is desirable.

职 责：
GMP Auditing and Analytical Testing:
Reviews pre-audit information submitted by VER participants and makes recommendations on the participant’s readiness for a formal audit.
Conducts cGMP site audits of active pharmaceutical ingredient (API), excipient, and dietary ingredient and dietary supplement manufacturing sites, according to the appropriate cGMP guidelines and VER program requirements.
Acts as an interpreter for VER during audits and ensures that translations performed by Chinese participating companies (both written and verbal) are accurately recorded.
Creates audit reports in a timely manner summarizing the results of the site audits and makes recommendations regarding site compliance with cGMP requirements.
Departmental Activities:
Develops and updates VER SOPs, participant manuals, and other documents periodically in collaboration with QA and VER Staff.
Effectively assists chemists who conduct major analytical work by ensuring testing is carried out in accordance with the project plan.
Reviews and manages internal audit reports of VER participants and coordinates with VER to respond and initiate corrective action for audit findings.
Work closely with Customer Relationship Management team in China to develop new customers.
Responsible for China supplier management, including database management, evaluation of critical/special suppliers, etc.
Secondary Responsibilities:
Conducts site audits of active pharmaceutical ingredient (API) and dosage form manufacturers for Global Health Impact Program (GHIP), when required.
Prepares audit reports summarizing the results of the site audits and makes recommendations to the Program Manager – GHIP regarding site compliance with cGMP requirements.

中智上海经济技术合作有限公司（简称中智上海公司）是中智全国性服务网络战略布局中重要的战略成员。目前，中智上海公司服务2万余家客户企业，雇员数达77万。公司主营业务包含：人力资源外包、招聘+业务外包、国际业务、培训业务和贸易服务五大板块。2013年，中智上海公司荣获由上海市政府颁发的“上海市质量金奖”。2016年，公司荣获由国家质检总局颁发的第二届“中国质量奖”提名奖。2018年，中智上海公司第一批获得由上海品牌国际认证联盟颁发的“上海品牌”荣誉。中智上海公司秉承“诚信、尊重、公正、专业”的服务精神，积极践行社会责任，不断追求卓越，持续为客户和雇员创造价值。
应聘者请发简历至 resume@ciicsh.com