Chemist I応募後で応募 求人ID R0035469 掲載日 06/15/2021 Location:Singapore, Singapore
Primary Objectives of this Job
This position is required perform all tasks associated with the QC analytical lab operations which include chemical analysis, biochemical analysis, equipment calibration/maintenance, records review, records approval, deviation/investigation write up/review, equipment qualification, method validation, method transfer and other tasks as assigned.
• Perform chemistry, biochemistry analysis of in-process samples, bulk drug substance (BDS), non-routine samples.
• Ensure tests assigned are performed in a timely manner in compliance to Standard Operating procedures
• Perform equipment calibration and maintenance.
• Perform review/approval of QC records/ log books.
• Perform trending of lab results.
• Initiate and participate in Out Of Specification (OOS), Invalid test and Lab Deviation Investigation Write-Up and assist in timely closure of laboratory invalid results, lab investigation and CAPA.
• Write/revise SOPs, forms, training qualifications (TQ) and risk assessments (RA).
• Act as a Subject Matter Expert (SME) to provide technical advice to QC Personnel in laboratory related troubleshooting e.g. lab equipment failure, method
• Provide appropriate training for the QC Analytical Team.
• Participate in method validation/ transfer or equipment qualification when necessary
• Ensure proper, safe handling and disposal of waste; ensuring a safe working environment.
• Carry out 5S and ensures good housekeeping of Analytical Lab area.
• Support and participates in Operation Excellence initiatives (such as GEMBA and GMP walk).
• Participate in projects towards improving safety performance and continuous improvement initiatives.
• QC Chemist may cover for another QC Chemist of similar functions/areas in his/her absence by signing documents on his/her behalf.
• Assist Supervisor to support internal and external compliance audits.
• Responsibility to adhere to any applicable EHS requirements.
• Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s Code of Conduct.
• Any other duties as assigned by supervisor.
Education and Experience Requirements
• Bachelor Degree in Chemistry, Biochemistry, Biotechnology or equivalent, preferably with more than 1 year of experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment.
• Demonstrated ability to collaborate with cross functional or cross sites to achieve objectives.
Key Skills and Competencies
• Project Management Skills
o Organization and planning skills
o Analytical and Logical thinking skills
o Ability to work and collaborate within the team
• Technical Skills
o Has substantial knowledge and understanding in terms of regulatory standards requirements e.g. USP, EP, 21CFR, ICH etc.
o Knowledge in Ion Chromatography (IC), High Performance Liquid Chromatography (HPLC), Fluorescence spectrometer (FLS), pH, Conductivity, Gel electrophoresis (SDS Page or Western Blot), Potency and ELISA
o Knowledge in Empower and LIMS.
o Knowledge in Microsoft Office.
• Problem solving
o Solves problems and implements corrective actions using six sigma tools.
• Be a subject matter expert in given areas of responsibilities and able to solve issues related to his/her area of expertise.
• Some knowledge in safety principles, practices, regulations and procedure related to the work.