Company
Pharmaceutical
SeniorSpecialistQualityControl-Analyticallab
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Specialist Quality Control-Analytical lab. Skills: Analytical methods, Quality control, Regulatory requirements. Manage instrument. Report deviation timely”
Industry & Context.
Lead critical deviation/OOS investigation
Purchase/ store/ use controlled chemicals, Take personal responsibility for security, Participate the necessary security training and drills, Strictly enforce the job safety procedures, Report any incidents, accidents and hazards in work timely
What They're Looking For.
Must Have
Bachelor degree in chemical, pharmaceutical and analysis related subjects, Excellent technical expertise in HPLC, MS, GC, AAS, UV, IR, NIR and other analytical methods in an industrial environment, Knowledge of and experience in analytical development, transfer and validation, Knowledge of and experience in quality and regulatory requirements under which pharmaceutical products are developed, commercialized and supported, Knowledge of global pharmacopoeia and relative regulations, such as ICH, FDA, EMEA regulations, 7+ years industry experience in the analytical area (Bachelor degree), 3+ years experience (Master degree), 2+ years experience (Ph. D degree), Fluent English skill in both oral and written, Good computer skill, Good communication and presentation skills, Good team work spirit, Sense of responsibility and work actively
Nice to Have
8+ years industry experience in the analytical area (Bachelor degree), 5+ years experience (Master degree), 3+ years experience (Ph. D degree)
What You'll Do.
Report deviation timely
Lead critical deviation/OOS investigation
Issue and revise specification
Batch analysis record revision
Purchasing specification revision
Prepare specification for application
Regulatory/change assessment
Lead function level project
SME of QC core system
Champion quality process
Follow SOP and Guideline
Fill in documentation
Participate in correction to observations
How You'll Work.
Team & Collaboration
Cross team communication and support
Communication Scope
Good communication and presentation skills
Process & Methodology
Lead function level project
Full Job Description
**Typical Accountabilities** **主要职责** **Specific Responsibilities/Tasks** **具体职责****/****任务** Routine work 日常工作 * Mangement of instrument * Report any deviation timely, lead critical deviation/OOS investigation * /OOS的调查 * Issue and revise specification, test method and batch analysis record of starting materials and finished products, and purchasing specification, test method for PQ, CQ etc. * Prepare specification for application (draft) and specification explanation * Regulatory/change assessment and change management * Lead function level project * Cross team communication and support * SME of QC core system * QC核心系统的专家 * Quality process champion S.H.E. Responsibilities SHE 职责 * Take personal responsibility for security to protect themselves and avoid harm to others and the environment * Participate the necessary security training and drills with the contingency project * Strictly enforce the job safety procedures * Report any incidents , accidents and hazards in work timely * Purchase/ store/ use controlled chemicals. * 危化品的采购、保管、使用 GMP compliance GMP 符合性 * Strictly following SOP and Guideline 严格执行岗位操作规程和指南 * Take GMP training and strictly following GMP compliance 参加GMP培训，严格遵守GMP与法规要求 * Fill in related documentation such as BAR, other logbook etc., timely to ensure the accuracy of content as per requirement of SOPs. * SOP的要求填写相关文件记录如批化验记录、仪器使用和维护记录等并保证内容的准确性 * Take part in actively in correction to the observations found in self-inspection. 积极参加对自检中所发现缺陷的整改 Training and development 培训和发展 * Participate actively in serials training required to be held by internal and external. * Develop all kinds of skills in relation to work field and pursue continuous improvement 发展各种工作技能并追求持续的改进 Others 其他 * Assist the lab manager in completing tasks when required. * Complete other tasks arranged according to business needs **Qualifications****资质** **Education, Experience and Training** **教育、工作经验和培训** * Academic/Professional qualification * /专业资格 * Minimum requirement a bachelo
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