The primary responsibility of this position is to ensure that all QC laboratories provide a compliant, timely and cost effective quality control service during the plant qualification phase and routine plant operations. The main services provided by Quality Control are the testing of samples, review and approval of results and ensuring the quality of the following: raw materials, in process and final bulk materials, finished product and stability samples as well as providing environmental monitoring, utility monitoring and ongoing project support.
- The position requires managing the Chemistry, Microbiology, Biochemistry and Cell Culture laboratories in order to deliver these services along with other agreed functional goals while maintaining an environment of continuous improvement, customer focus and awareness of business needs. This position will also be responsible for the coaching, developing and performance review of QC staff.
法規制の順守に関する責任REGULATORY COMPLIANCE RESPONSIBILITIES:
Lab operations must be compliant with the following laws and regulations (but not limited to)
- Narcotics and Psychotropics Control Law
- Official compendium such as JP etc.
- The Pharmaceutical Affairs Law
- EHS laws such as Poisonous and Deleterious Substances Control Law etc.
- Responsible for all QC activities such as Sampling, QC test, Storage samples, control of equipment, stability test, creation, review and approval of CoA, Validation, Market support and Outsourcing activities.
- The timely and compliant qualification of QC Analytical Equipment and Systems, training of QC Analyst on Method and Equipment.
- Approval of all required documentation related to QC.
- Timely completion of the Analytical Method Transfer process.
- Ensures operational readiness for all QC laboratories during project and routine phase.
- Manages the QC departments to provide compliant, timely and cost effective QC support to the plant.
- Manages the QC department's budget - human resources, overheads and capital expenditure.
- Defines Quality Control Policies, in consultation with QA and corporate guidelines.
- Anticipates and plans for future requirements in the area, including such aspects as procedural requirements, capital planning, personnel recruitment planning, compliance requirements, and efficiency developments and anticipated changes needed to reflect future demand for services.
- Leading and supporting the qualification of QC activities
- Sampling and testing coordination during plant and laboratory utility qualification.
- Co-ordinates & plans activities related to the successful transfer of Analytical Methods.
- Implementation of Analyst Training programs to ensure that analysts meet required competency.
- Review, ensure and approve laboratory test results.
- Ensure QC activities are carried out in compliance with GMP and company quality and safety standards.
- Achieves competency in Fuji QC laboratory methods and procedures.
- Writes and reviews laboratory document (SOPs and WIs) as directed by company policy.
- Deals with non-conformance/deviations in an accurate and timely manner.
- Maintains and develops knowledge of analytical technology as well as GMP standards.
- Developing and implementing safety procedures within the laboratory.
- Ensure all activities comply with EHS requirements.
- Comply with confidentiality agreement.
- Provide QC staffs with opportunities, such as external GMP workshop, in order to bring new GMP knowledge into Quality Control Group.
Share the knowledge learned from external workshop through internal GMP training, and increase the frequency of internal GMP training.
- Ensure QC staffs to conduct monthly GEMBA walk in the Quality Control area, and address observations to prevent recurrence for continuous improvement.