Senior Specialist Quality Control (Analytical Lab)

Typical Accountabilities 主要职责 Routine work 日常工作  • Mangement of instrument • undefined • Report any deviation timely, lead critical deviation/OOS investigation   • undefined • 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. • undefined • Prepare specification for application (draft) and specification explanation • undefined • Regulatory/change assessment and change management • undefined • Lead function level project • undefined • Cross team communication and support • undefined • SME of QC core system • undefined • Quality process champion • undefined S.H.E. Responsibilities SHE 职责 • Take personal responsibility for security to protect themselves and avoid harm to others and the environment • undefined • Participate the necessary security training and drills with the contingency project • undefined • Strictly enforce the job safety procedures • undefined • Report any incidents , accidents and hazards in work timely • undefined • 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. • undefined • 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. • undefined • 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. • undefined • Complete other tasks arranged according to business needs • undefined   Qualifications资质 Education, Experience and Training 教育、工作经验和培训 Academic/Professional qualification 学历/专业资格 - Minimum requirement a bachelor degree in chemical, pharmaceutical and analysis related subjects 最低具有药学、化学和分析相关专业本科学历 • Technical/skills training 技术/技能训练 - Excellent technical expertise in HPLC, MS, GC, AAS, UV, IR, NIR and other analytical methods in an industrial environment is required. 拥有优秀的专业技术能力，如在工业生产领域掌握HPLC, MS, GC, AAS, UV, IR, NIR等分析技术。 - Knowledge of and experience in analytical development, transfer and validation is required. 要求具有分析方法开发，转移和验证的工作经验和知识。 - Knowledge of and experience in quality and regulatory requirements under which pharmaceutical products are developed, commercialized and supported. 基于质量和法规需求，具有药品开发、商业生产和技术支持领域的相关知识和工作经验。 - Knowledge of global pharmacopoeia and relative regulations, such as ICH, FDA, EMEA regulations is required 要求具有全球药典和其他相关法规的知识，如ICH, FDA，EMEA等。 • Working experience 工作经验 - Essential 必需 A Bachelor degree with minimum 7+ years industry experience in the analytical area, or A Master degree with minimum 3+ years experience, or A Ph.D degree with minimum 2+ years experience; 本科需有7年以上分析工作经验，硕士3年以上，博士2年以上。 - Desirable 理 想 A Bachelor degree with minimum 8+ years industry experience in the analytical area, or A Master degree with minimum 5+ years experience, or A Ph.D degree with minimum 3+ years experience; 本科需有8年以上分析工作经验， 硕士5年以上，博士3年以上。 Capabilities 能力 • Language ability/ 语言能力 Fluent English skill in both oral and written 流利的英文交流和读写能力 • Computer literacy/电脑知识 Good computer skill 良好的计算机能力 • Communication ability/ 沟通能力 Good communication and presentation skills 良好的沟通和展示技能 • Others/ 其他 Good team work spirit 良好的团队合作精神 Sense of responsibility and work actively 富有责任心及工作积极 Date Posted 03-Nov-2026 Closing Date 30-Jan-2027 AstraZene