QC Testing Manager/Senior Manager- API QC - Tuas

Requirements:

• 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.