|部署・役職名||Director － Quality Control Laboratory|
－ Accountable for planning, organizing, implementing and controlling all activities of the QC laboratory to ascertain that raw materials, mass and finished goods meet internal and external specifications.
－ Will work collaboratively with the QA Lab Lead to oversee the development and implementation of corporate and local SOPs supporting product release, ensure all lab processes are adhering to relevant regulatory GMPs and global company policies ＆ procedures, and drive CAPA development and execution.
－ Provide leadership, direction and expertise to drive the laboratories towards continuous improvement.
－ Direct responsibility for managing QC laboratory staff and their growth and development.
－ Establish and maintain lab safety program and ensure lab operations are in compliant with the company and regulatory requirements.
－ Set Up of SOP ＆ Management of QC Lab Testing （55％）
ー Testing Data Review and Release － Data Reviewer role responsibilities （％varies by site）
ーEquipment Program （10％）
ーCompliance / Continuous Improvement （15％）
ーPersonnel Management ＆ Training （20％）
【必須（MUST）】• Minimum 10 years experience in managerial positions, preferably in microbiology, analytical chemistry or product evaluation laboratories in Quality Control for a global consumer goods or pharma company
• Demonstrated ability to successfully run multiple laboratories in a cGMP environment.
• Experience in developing and overseeing laboratory SOPs and revisions according to regulatory guidelines
• Experience in dealing with microbiological and analytical chemistry data integrity requirements necessary in an HC / FDA/ global government agency inquiry and/or audit
• Excellent communication and coaching skills. This includes the ability to communicate with the Quality Control team members clearly and concisely regarding quality control issues, quality control requirements, implementation of quality control programs, and corrective ＆ preventative actions where required. Ability to communicate information to cross－functional stakeholders and suppliers.
• Experience and/or knowledge in lab hazard analysis and safety.
• Strong leadership and human relation skills
• Excellent problem solving skills
• Expertise in statistical assessment of data
• Proficiency in Microsoft Office Suite, Electronic QMS, and SAP systems is preferred