Associate Director Quality Control
- Wuxi, Jiangsu
- Permanent
- Full-time
- Establish optimal operation pattern in the analytical group and build high efficient team to achieve top decile productivity target
- Manage routine analysis for products and materials to deliver accurate test results in a timely manner.
- Establish, develop and manage products and materials test system to make sure that quality of product meets internal and regulatory requirements.
- Ensure schedule adherence for analytical samples, Deviations and CAPAs, Change controls and Change action items, Lab Investigations, special projects
- Organize group tier meetings, and conduct layered audit and relevant process confirmation to ensure timely exposure/escalation of risks/issues.
- Regulatory/change assessment related to analytical process
- Technical review and approval of technology transfer and method validation/verification
- Organize group tier meetings, and conduct layered audit and relevant process confirmation to ensure timely exposure/escalation of risks/issues.
- Regulatory/change assessment related to analytical process
- Technical review and approval of technology transfer and method validation/verification
- Technical review and approval of technical assessment report
- SME of core analytical process
- Rational budgeting for analytical group resources, like investment, expenditure and headcount, and achieve finance target
- Other Project/task assigned upon business needs
- 完成其他业务驱动的项目和任务
- Lead and provide guidance in the daily job of the team.
- Set clear direction and objectives and motivate and encourage all staff
- Optimize performance outcomes of direct reports and ensure high quality IDP review
- Own people performance development of the analytical group
- Develop all kinds of skills in relation to work field and pursue continuous improvement
- Ensure compliance of analytical group with GMP, GLP, corporate standards or regulatory
- Support self-inspection and coordinate audits from authority or GQA
- Promote a SHE focussed culture to achieve excellent SHE target
- Implement SHE Policy and Standards and ensure compliance with local legislation at daily work
- Proactively identify SHE risks and take appropriate action
- Seek suitable method and technology to address the SHE risks or issues
- Solve all SHE problems and communicate with SHE team
- Degree or equivalent professional qualification in a science/technical field such as Pharmacy, Biology, Chemistry.
- Has experience in pharmaceutical quality control lab.
- Sound knowledge of the analytical work
- Sound knowledge of the principles and concepts of Good Manufcaturing Practice/ Good Laboratory Practice.
- Sound knowledge and understanding of SHE principles
- Sound knowledge in analytical transfer and validation, related experience is preferred.
- Sound knowledge of main global pharmacopoeia and relative regulations.
- Functional mastery of written and spoken English
- 熟练掌握书面和口语英语
- Proficient in time management
- 精通时间管理
- Good computer skill
- 良好的交流沟通能力，强烈的责任心
- Good people management skills
- 良好的人员管理技能
- Competent in problem solving and risk analysis
- 能够进行问题解决和风险分析
- Mastery of risk/issue escalation skills
- 掌握风险和问题上报技能