Responsible for the daily operation and management of the analytical lab, ensuring smooth progress of release testing.
Organize lab events, deviations, and OOX investigations occurring during GMP testing.
Responsible for building the capability of the team, developing new business capabilities (such as oligonucleotide & peptide), and cultivate a talent echelon.
Responsible for the paperless construction and maintenance of analytical lab, such as ELN, LIMS, etc.
Ensure personnel are qualified through training and maintain continuous training and assessment.
Organize timely data review by personnel to ensure related deviation investigations are completed before product release.
Maintain good communication with same business laboratories of other sites, ensuring consistency in documentation systems and execution processes.
Participate in the maintenance and optimization of processes to ensure personnel are following the procedures.
Participate in customer audits and government inspections, promptly complete rectifications of findings, and ensure GMP compliance.
Timely track work progress, strengthen communication with internal and external customers, and establish stable and good relationships.
Ensure laboratory safety and personnel safety.
Responsible for other tasks temporarily assigned.
Assist department leaders in building a high-efficiency team.
Enhance the team's capabilities for new business to meet new business requirement.
Bring out the initiative, enthusiasm, and creativity in each team member.
Energize the entire team.
Any ad-hoc tasks assigned by supervisor.
Responsibilities:
Pharmacy or chemical related major, bachelor's degree or above.
Understand pharmaceutical production, microbiology, testing, and quality management; familiar with GMP regulations.
Proficient in English and Chinese, fluent in spoken English and Chinese, to communicate with internal stakeholders in China HQ.
Good computer skills.
Over 5 years of work experience, with more than 3 years in managing a GMP analytical team.
Good coordination and communication skills.
Ability to determine problems, gather information, understand facts, and draw correct and effective conclusions through scientific reasoning.
Project management and tracking skills.
Guide and supervise the work of subordinates.
Responsible for assigning work, assessing, and motivating subordinate employees.
Open for 3-6 months training in China Changzhou/Taixing.
