Be responsible for establishment, routine operation, maintenance, improvement of Lab. system and SOPs.
Be responsible for qualification, validation of Lab. System and equipments.
Lead QC team to meet the preset goal/budget of department through streamlining/optimizing the workflow and maximizing the operation efficiency while maintaining full compliance.
Develop QC team including planning, recruiting, coaching, and training for staff. Provide technical guidance/direction to subordinators.
Be responsible for sampling, testing of materials, intermediates, finished products according to defined procedure or specification.
Participate in SHE, Business Compliance, cGMP, and all other compliance-related matters, where applicable.
Any other tasks as and when assigned by superior.
Requirements:
At least BS degree in analytical chemistry or other directly- related science.
Must be proficient with the requirements of the s-FDA/US-FDA/ EMEA cGMP regulations, ICH guidelines as well as drug development process.
More than 8 years experience in GMP in analytical or pharmaceutical industry
Strong interpersonal and leadership skills to participate actively to virtual teams & communicate, collaborate, negotiate & persuade across a broad variety of functions, companies and cultures.
Problem solving ability and adept guidance of formulation teams is also required.
Ability to work independently as well as in teams and represent Wuxi to clients.
She/he must develop strong collaborative relations with clients and internal customers/stakeholders across divisions to execute her/his responsibilities in assigned projects.
