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Quality Control Development Analyst

  • June 12, 2017

Quality Control Development Analyst

Our pharmaceutical client located in Brampton, On is looking for an experienced candidate to fill this one year contract position.

The main responsibility for this position is to perform method development, validation and transfer activities to support Quality Control and Operations (Development).

Responsibilities:

  • Develop and validate methods within the QC lab for HPLC and other instrumental techniques with the goal of updating and improving existing methods.
  • Develop and validate cleaning validation methods as required.
  • IV Drug release testing for product comparison.
  • Perform process validation and cleaning validation testing.
  • Perform method transfer activities.
  • Support new product introduction.
  • Product, method and raw material trouble shooting.
  • Participate on projects in the area of focus related to process improvement.
  • Collaborate with other departments to proactively build quality into the processes and systems.
  • Create and revise QC procedures as required.
  • Provide support for internal and Regulatory Inspections.
  • Identify and implement key process improvements to enhance systems, gain site efficiencies and elevate GMP requirements.
  • Generate, gather and analyze data for reporting purposes.
  • Complete all GMP Documentation correctly and in a timely manner.
  • Complete all training assignments and maintain personal training records.
  • Participate in and/or lead Non Conformance Investigations.
  • Complete Corrective and Preventive Actions (CAPA’s).
  • Initiate, and follow through with actions required to close Change Controls.
  • Participate in Internal, Customer and Regulatory Audits.
  • Ability to influence others while maintaining integrity and trust, by keeping a continuous focus on effective communications to ensure achievement of shared goals.
  • Other duties as assigned.

Requirements:

  • Sc. in Chemistry or related discipline.
  • Minimum 3-5 years’ experience within the pharmaceutical industry in a quality control laboratory environment.
  • Expert knowledge and understanding of analytical chemistry and instrumentation.
  • Proficiency with analytical instrumentation (pH meter, viscometer, Karl Fisher apparatus, UV, IR, HPLC, GC, UPLC).
  • Knowledge of applicable software including LIMS, Empower and MS Office.
  • Strong knowledge and application of Health Canada and FDA regulations.
  • Excellent written communication, both written and verbal
  • Strong report writing and technical writing skills.
  • Strong organizational skills and ability to multi-task; detail oriented.
  • Excellent problem solving, judgment, interpersonal and teamwork skills
  • Advanced ability in investigative techniques to troubleshoot analytical problems.

** Career Connections Canada Inc. welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. To request an accommodation, please contact Career Connections Canada Inc..

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