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 86 Lead pharma QC team including QC lab (perform chemical, microbiological, functional control as well as routine clean environment monitoring) to achieve various KPIs 86 Introduce best practice(Risk-based Approach etc.) in QC dept to improve overall working efficiency as well as assuring GMP compliance 86 Develop young talents , build a strong and sustainable QC team to support pharma business development 86 Lead gap analysis of exposure drafts (related to packaging material) of CP2025 collaborating with RA and Scientific dept , implement associated actions within due date. 86 Maintain local bunding registration standard as well as SOPs related to QC dept according to CP2025 and GMP requirements. 86 Support Internal/External customer in terms of Quality Specification, Control Method; Conduct YBB study for sister company to support their product bundling registration. 86 QC lab method (re)validation and QC instrument (re)qualification per USP 1058 86 Support qualification for new project and product 86 Other tasks assigned by manager.
Required Qualifications 86 Bachelor’s degree or above with Chemistry or Pharmacy related majors. 86 More than 5 years’ experience in laboratory work (chemical analysis is preferable) and lab project introduction or transfer. 86 Familiar with ICH, CP and GLP 86 Good communication skills in both Chinese and English. 86 Outgoing, self-motivated, and creative thinker.