Manager, QC & Lab

This position aims to enhance local Pharma quality organization as well as to lead continual improvement and assuring the compliance of quality control practices against Aptar pharma procedures as well as applicable regulations  This position aims to enhance local Pharma quality organization as well as to lead continual improvement and assuring the compliance of quality control practices against Aptar pharma procedures as well as applicable regulations 

Primary Duties and Responsibilities

• Lead pharma QC team including QC lab (perform chemical, microbiological, functional control as well as routine clean environment monitoring) to achieve various KPIs
• Introduce best practice（Risk-based Approach etc.） in QC dept to improve overall working efficiency as well as assuring GMP compliance
• Develop young talents , build a strong and sustainable QC team to support pharma business development 
• Lead gap analysis of exposure drafts (related to packaging material) of CP2025 collaborating with RA and Scientific dept , implement associated actions within due date.
• Maintain local bunding registration standard as well as SOPs related to QC dept according to CP2025 and GMP requirements.
• Support Internal/External customer in terms of Quality Specification, Control Method; Conduct YBB study for sister company to support their product bundling registration.
• QC lab method (re)validation and QC instrument (re)qualification per USP 1058
• Support qualification for new project and product 
• Other tasks assigned by manager.

Required Qualifications

• Bachelor’s degree or above with Chemistry or Pharmacy related majors.
• More than 5 years’ experience in laboratory work (chemical analysis is preferable) and lab project introduction or transfer.
• Familiar with ICH, CP and GLP
• Good communication skills in both Chinese and English.
• Outgoing, self-motivated, and creative thinker.