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Senior Chemist Job Singapore,  

Posted on : 10 April 2017

Project Description

Senior Chemist-QUA005338DescriptionOverview- Responsible for planning, scheduling and performing laboratory testing of raw materials, packaging components, excipients, in-process control samples, intermediates, semi-finished products, final drug substances and finished products manufactured in API West, Biotech, Pharm West and Pharm South Facilities.- Responsible for ensuring the analytical methods / specifications used are in accordance with requirements specified in MSD Quality Standards, regulatory dossiers and pharmacopoeia.- Manage the calibration, maintenance and qualification of laboratory equipment.- Conduct laboratory investigation on laboratory equipment failure, OOT and OOS.- Responsible for testing of developmental and clinical products as required.- Participate in analytical developmental activities as required.Responsibilities- Perform analytical testing on incoming raw materials, packaging components and excipients.- Carry out testing activities associated with release and stability testing of the in-process control samples, intermediates, semi-finished products, final drug substances & finished products.- Ensure tests assigned are performed in a timely manner in compliance to Standard Operating procedures with necessary laboratory safety precautions.- Carry out cleaning sample testing related to any equipment or facility cleaning activities.- Co-ordinate with respective IPT facilities on the timing of drug substances change-over.- Perform second person verification of other analysts  work.- Liaise and coordinate with external service providers in carrying out calibration/maintenance of lab equipment and tools when necessary.- Carry out lab equipment calibration and proper documentation of all instruments in laboratories.- Closely work with supervisor on the requirements of swabbing samples and to identify the appropriate sampling location and take swab samples for testing.- Participate in analytical method transfer / validation and equipment Qualifications when necessary.- Perform periodic reviews of existing cleaning method validation package & procedure, and to implement corrective actions for the periodic reviews.- Assist in writing protocol to support method transfer/validation, compendial method verification and equipment qualifications when necessary.- Conduct in Laboratory investigation using 5 whys & fishbone to identify the root cause and its report writing. Ensure laboratory related actions are effectively implemented within agreed time frame, to continually improve processes, prevent waste, and eliminate rework.- Provides inputs to new Quality Standards and Standard Analytical Tests; implementing new Quality Standards once approved and obsoleting previous revisions- Revise and write Standard Operating Procedures (SOPs) to reflect the current practice and ensuring that the current level of standard are met.- Oversee Annual Product Review to ensure that the activities are completed by the required timelines- Perform and maintain an acceptable level of good laboratory housekeeping.- Maintain inventory and control in-house stock, reference standards, chemical reagents, and consumables and ensure that there are sufficient stocks for testing.- Identify and execute laboratory efficiency improvement tasks, e.g., Kaizen.- Facilitate training of new recruits and generate the necessary training records and Analyst Qualification and Re-qualification Form (AQRF) for the trainee.- Revise and write Standard Operating Procedures (SOPs) to reflect the current practice and ensuring that the current level of standard are met.- Assist in responding to queries raised by regulatory agencies pertaining to analytical standards and methods.- Assist in periodic review of laboratory procedures and ensure that current practices and standards are incorporated and reflected in the procedures.- Responsible for release of batch results- Supports Laboratory related metrics analysis and reporting- Ensure all staff are appropriately trained and qualified to execute the duties assigned to them with respect to job, cGMP, GLP and SHE expectations as defined in the training matrix- Schedule periodic review of test procedure to ensure the test methods and specifications are in line with current requirement specified in MSD Quality Standards, regulatory dossiers and pharmacopoeia.- Work closely with global compendial group in reviewing of compendial changes and revise site test procedure and specification if necessary.- Review of all the tests datasheet / worksheet records to ensure that the testing results are within SPC limits and meet Product Specification.- Participate in SHE, Business Compliance, cGMP and all other compliance-related matters, where applicable.Qualifications- Bachelor Degree in Chemistry/ Biochemistry.- 4  6 years experience in pharmaceutical analysis is preferred.- Demonstrable experience and competency in Particle size analyzer, GC, HPLC, Karl Fischer Titrator, spectroscopic and wet chemistry testing is preferred.- Demonstrated knowledge and application of sound scientific principles, theories, techniques and skills- Technical competency in analytical troubleshooting.- Demonstrated knowledge and understanding of cGMP, GLP, and associated regulatory expectations related to Pharmaceutical Analytical Testing and Release- Potential to teach and coach the team on technical and business process elements of analytical testing.Job: Quality Lab Related Job Title:Spclst, Quality ControlPrimary Location: APAC-SG-Singapore-SingaporeEmployee Status: RegularTravel: NoNumber of Openings: 2Company Trade Name:MSD Job Segment: Biochemistry, Housekeeping, Chemist, Biotech, Science, Healthcare, Hospitality


Singapore, SG

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