Senior QC Chemist (Pharmaceutical/ Chemical industry)

Location Singapore
Discipline Engineering
Job Reference BBBH131457_1698023131
Salary S$5000 - S$6500 per month
Consultant Name Fenny Tan Cheu Hoon
Consultant Name Fenny Tan Cheu Hoon
Consultant Email [email protected]
Consultant Contact No.
Consultant Contact No. 6232 8833
EA License No. 02C3423
Consultant Registration No. R22105896
Consultant Registration No. R22105896


Role Purpose

  • The incumbent is a member of the QC laboratory team, reporting to the QC System Manager/ QC Supervisor.
  • Ensure all data management for QC instrument/ equipment analysis data comply to site SOPs, Data Integrity (DI) and ALCOA requirements per PQS and that they are archived/ retained in accordance to existing procedures.
  • Perform all activities in the system life cycle of QC lab instruments/ equipment (selection, qualification, user management, calibration, preventive maintenance, periodic reviews, configuration and electronic data management, decommissioning) in accordance to approved site procedures and applicable standards.


Responsibilities

  • Provide operational support (e.g. troubleshooting) for QC lab instruments/ equipment to ensure batch release and lab testing activities is maintained inline with committed schedules.
  • Develop, maintain and communicate QC laboratory testing/ release capacity planning based on demand forecasts, testing/ release lead times, resource availability (equipment, manpower) and budget requirements.
  • Collaborate in cross functional teams to provide inputs and adjustment to test activities to support production/ product shipment/ NPI.
  • schedules with appropriate escalation through Tier processes.
  • Provide QC support of Continued Process Verification and Annual Product Review processes, including Stability and Batch testing data analysis and review.
  • Involve in investigations for deviations affecting QC laboratory systems or processes (e.g. Equipment failure, Stability-related investigation), identify root cause(s) and implement appropriate corrective action and preventive measures.
  • Subject Matter Expert for area of work scope (e.g. Equipment qualification and maintenance program, Stability program, Analyst training program) and ensure adherence to site procedures and PQS.
  • Involve in projects for improvement of QC laboratory systems and processes including Data Integrity initiatives.
  • Subject Matter Expert for area of work scope (e.g. Equipment qualification and maintenance program, Stability program, Analyst training program) and ensure adherence to site procedures and PQS.
  • Play an active and impactful role in Tier processes by updating performance against metrics, highlighting & resolving issues, with appropriate escalations. Develop courses of action and drive implementation of solutions.


Qualification and experience

  • Degree or Diploma in Science (preferably Chemistry) or Chemical Process Technology.
  • 4-8 years QC experience in the pharmaceutical or chemical industry.



Key Skills & Attributes

  • Comprehensive knowledge of analytical laboratory equipment system life cycle and data integrity requirements.
  • Comprehensive knowledge of cGMPs and QC processes (Stability program management, QC Analyst training programs, Continued Process Verification and Annual Product Review).
  • Familiarity with statistical software (e.g. Minitab) and data analysis.
  • Embrace the use of digital technology to scale and speed up every form of interaction and action.

Tan Cheu Hoon, Fenny EA License No.: 02C3423 Personnel Registration No.: R22105896

Please note that your response to this advertisement and communications with us pursuant to this advertisement will constitute informed consent to the collection, use and/or disclosure of personal data by ManpowerGroup Singapore for the purpose of carrying out its business, in compliance with the relevant provisions of the Personal Data Protection Act 2012. To learn more about ManpowerGroup's Global Privacy Policy, please visit https://www.manpower.com.sg/privacy-policy