- 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.
- Bachelor Degree in Chemistry/ Biochemistry.
- 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.
Other Competencies and Personal Attributes:
- Effective written and verbal communication skills
- A good team player with ability to handle task independently
- Understands of the IPT value stream and customer focused
- Good time management skills
- Continuous improvement mindset
- Self-motivated with strong analytical skills
- Ability to coach, motivate and lead others through change
- Analytical development mindset in research and commercialization activities
Job: Quality Lab Related Job Title:Assoc. Spclst, Quality Control
Primary Location: APAC-SG-Singapore-Singapore
Employee Status: Regular
Number of Openings: 3
Company Trade Name:MSD
Job Segment: Biotech, Biochemistry, Housekeeping, Chemist, Science, Hospitality, Healthcare