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Production Investigation Specialist - Jobs in North York, ON

Dalton Pharma Services
Job LocationNorth York, ON
EducationNot Mentioned
SalaryNot Disclosed
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeFull Time

Job Description

Production Investigation SpecialistGeneral Summary: The main responsibility for this position is to provide compliance support to meet Dalton Chemical Laboratories requirements and ensure that all activities related to investigations are completed thoroughly and in a timely manner.This role requires a bachelor’s degree in Life Sciences, Engineering, or related field and over 5 years pharmaceutical experience preferably in quality management or manufacturing. Work on site.Primary Duties and Responsibilities:

  • Independently investigate non conformances and preventing reoccurrences in support of manufacturing operations. Initiate investigations for problems associated with a wide variety of quality issues.
  • Interview operators, stakeholder department personnel to assure comprehensive Root Cause Analysis and Root Cause determination to prevent reoccurrences. Review GMP logbooks, Master Batch Records, Master Work Sheets, Protocols, Reports, Change Controls, and Test Specifications in support of investigations. Provide group training on systematic gaps observed during investigation.
Knowledge, Skills and Abilities:
  • In-depth knowledge of GMP regulations. Technical writing is an asset. Excellent communication (oral and written) and attention to detail. Advanced computer skills.
  • Have an understanding of biologics, sterile liquid and powder, and API manufacturing operations. Prioritize multiple assignments and changing priorities. utilize computerized systems for daily performance of tasks.
  • Ability to work independently and as part of a team in a client facing environment. Ability to conduct review of batch records, logbooks; raw materials, components, intermediates, and final products documentation for investigational purposes.
For more information visit our website: www.dalton.comWhile we appreciate all applications received, only those selected for an interview will be contacted.Job Types: Full-time, PermanentSalary: $55,000.00-$65,000.00 per yearBenefits:
  • Casual dress
  • Dental care
  • Extended health care
  • Paid time off
  • RRSP match
  • Vision care
Schedule:
  • 8 hour shift
Ability to commute/relocate:
  • North York, ON: reliably commute or plan to relocate before starting work (required)
Application question(s):
  • Do you live in the Toronto Area GTA
Education:
  • Bachelors Degree (preferred)
Experience:
  • pharmaceutical: 5 years (preferred)
  • quality management or manufacturing: 5 years (preferred)
  • GMP regulations: 5 years (preferred)
  • API manufacturing operations: 3 years (preferred)
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