| Senior QC Analyst (Raw Materials)-000006AL Description Duties and Responsibilities include but are not limited to: · Analysis of raw material samples according to Standard Operating Procedures and Test Methods · Equipment qualification and technical selection of QC equipment and/or standards and reagents · Method transfers and method validation · Assay trend analysis · Problem solving of analytical methods as well as troubleshooting of equipment · Demonstrated ability to lead/ direct lab based projects (i.e. method validations, transfers etc) · Authoring deviation reports, change controls and other standard industry documentation requirements · Carry out assessment of regular compendia revisions to ensure the lab’s compliance with the current revision of EP, JP and USP compendia · Training of analysts and technicians as required · Documentation of results in accordance with current Good Manufacturing Practices (cGMP) · General lab support including equipment maintenance, inventory of supplies, etc. Specific Areas of Responsibility: · Analytical/Biochem Area: Understanding and execution of spectroscopy, and other assigned methods which may include chromatography methods, ELISA, osmolality and other physiochemical methods. · Raw Materials Area: Understanding and execution of compendial monographs, chemistry fundamentals behind methods. Technology/equipment may include IR, polarimetry, refractometry, density meters, titrations (manual and automatic), atomic absorption, gas chromatography, wet chemistry techniques. Advancement to next level based on evaluation of the following: · Demonstrated process, equipment and system/GMP expertise. · Understanding of the theory and practical aspects of methods · Knowledge of equipment including troubleshooting techniques · Display dependable, positive team oriented attitude, initiative, and develop positive leadership skills in a corporate environment · Make company wide contributions, relating to expenditures, budget, efficiency, etc… · Individual should demonstrate responsible attitude appropriate to a corporate environment · Demonstrate solid cGMP knowledge · Demonstrated initial concepts of mentoring peers · Demonstrated ability to communicate effectively in professional manner with customers · Demonstrated success at all aspects of current role · Performing current duties and responsibilities for a minimum of 2-3 years Any other duties as assigned by your Supervisor/Manager Qualifications · Degree/Diploma in a relevant Science field or Equivalent · 4-8 years of relevant work experience preferably Lab experience in a biotech or medically related field · Understanding of cGMP regulations · Good problem solving and analytical skills · Good communication skills · Good to excellent written English Please send your CV to careers.singapore@lonza.com and stating the job title in the header. Only shortlisted candiates will be notified. | 
No comments:
Post a Comment