- 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.
- 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.
- Any other duties as assigned by the Supervisor / Manager.
In addition to the responsibilities of CHEMIST:
- 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.
- Bachelor Degree in Chemistry/ Biochemistry.
- Prior working experience is preferred.
- 0 – 3 years experience in pharmaceutical analysis is preferred.
- Experience in operating laboratory equipment such as Particle size analyzer, GC, HPLC, Karl Fischer Titrator is preferred.
- 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:Chemist / Senior Chemist
Primary Location: APAC-SG-Singapore-Singapore
Employee Status: Regular
Company Trade Name:MSD
Job Segment: Chemist, Biochemistry, Biotech, Housekeeping, Chemical Research, Science, Hospitality, Engineering