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Quality Systems Senior Manager

  • June 12, 2017

Quality Systems Senior Manager

Responsibilities:

  • Develop, maintain and monitor Quality Systems to ensure they are compliant to cGMP
  • Support GMP activities performed in the facilities in order to ensure their compliance to the highest level of regulatory requirements
  • Ensure that the site is compliant to an “in-use” state of the process and system associated to SOP and Documentation control
  • Ensure that the site is compliant to an “in-use” state of the process and system associated to training requirements, Annual Product Review, Change Control, CAPA Management, Stability Programs
  • Develop SOPs as required
  • Complete all GMP Documentation correctly and in a timely manner
  • Complete all training assignments and maintain personal training records
  • Complete Corrective and Preventive Actions (CAPA’s)
  • Initiate, and follow through with actions required to close Change Controls
  • Ability to follow moving priorities
  • Other duties as assigned

Requirements:

  • B.Sc. Chemistry or other associated field
  • 10 years’ experience at the supervisory/management level in the pharmaceutical industry
  • Experience with semi-solid dose products
  • Other duties as assigned
  • People oriented style of leadership
  • Complete knowledge of pharmaceutical operations
  • Complete knowledge of GMP, GLP, FDA, HPFBI
  • Excellent communication skills, both written and verbal
  • Strong organizational, coaching, interpersonal, technical and time management, problem solving, and multi-tasking skills
  • Strong knowledge and application of pharmaceutical, Health Canada and FDA regulations
  • Solid knowledge of applicable software, statistical, trending and risk analysis skills

** 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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