Scientist

Location:

Mississauga, ON

Date Posted:

4/7/2022

Job Number:

JO-2204-1418

Department: Quality(Analytical Compliance & Support)
Reports to:Supervisor, Analytical Compliance and Support

This is a Permanent Full - Time Position

Job Summary:
To provide support and service for the lab including method development and method validation for Rapid ID (Raman) methods for raw materials, qualification of new instruments, current instrument maintenance, decommissioning of aging equipment, Rapid ID program maintenance /Deviation management, method assessment, Empower Administration, related tasks supporting labs (reviewing methods, scripting Empower new projects) and building new procedures for the new equipment and other supporting lab activities.

Key Responsibilities:

• Leading the Rapid ID program for raw material release program to improve work efficacy for the lab and warehouse. Perform Method development and validation work for Rapid ID program for raw materials. Monitor Raman ID method robustness in the system. Being SME for Rapid ID program during auditing inspection to face auditor and answer questions.
• Perform instrument qualification work. Develop test cases for Performance verification work based on site application procedures and perform PQ test case for instrument qualification. Write instrument qualification report. Develop operational procedure for new instrument and draft operational SOPs for the new instrument application.
• Author method development and validation reports, position paper for site practice on Rapid ID program and draft new SOPs / Master forms and update SOPs for procedure change.
• Support method assessment related tasks including reviewing new methods, scripting new projects for the methods in Empower and the LIMS-Empower interface.
• Being an Empower super lead user to script Empower project including instrument methods, sample set and processing methods. Figure out calculation approaches in Empower and make the process easier for the lab. Routinely support Empower for issues in data processing, instrument method/sample set/processing method modification and instrument connecting issue.
• Review calibration reports, stability experiments under comparator’s study and new methods.
• Perform OOS investigation for Raman raw material release and instrument calibration failure and author investigation report or instrument deviation report.
• Prepare Investment plan for the purchasing of new equipment.
• Raise planned changes for introduction of new equipment and related decommission of instruments etc.
• Perform experiments to build suitable instrument parameters for the method on the new instrumentation and develop procedures.
• Perform analytical testing including calibration and perform retain verification work.

Educational Background:

• Minimum level of education : BSc. In Chemistry (Preferred Level of Education : BSc. In Chemistry or higher).
• Area of specialization: Chemistry.

Job - Related Experience:

• 5+ years in pharmaceutical industry involving Empower administration, development/administration of a raw material Rapid ID program.

• Skills set in the area Method development/method validation/method transfer/method equivalence help to deliver this job well (The skill set helps to understand the challenge encountered during method development/method validation work and figure out a way forward, build systematic approaches figure out new operational procedures when new instrument delivers or develop a method that was operating on the different instrument that will be obsolete or figure out the root cause of failure during calibration or method development or etc.).
• Statistic knowledge gain from previous work experience helped to understand the statistic application in data evaluation in Rapid ID program and method equivalence.