Investigation Specialist

4 weeks ago


Montreal, Quebec, Canada Pharmascience Full time
Job Title: Spécialiste Investigation AQ

The QA Investigation Specialist is responsible for conducting thorough investigations, reviewing and coordinating non-conformance reports and deviations occurring in PMS plants. He evaluates risks and impacts on patients, systems and product quality. He issues CAPAs to prevent occurrence and/or recurrence and contributes to the trends analysis report generation.

Responsibilities & Duties
  • Coordinates raw material, manufacturing and packaging lot, utility, OOS lab results, or general GMP non-compliance investigations:
  • Information gathering
  • Root cause investigation
  • Patient, product and systems risk evaluation
  • Corrective and preventive actions recommandation
  • Completes investigations tasks related to complaints management system
  • Performs or validates Initial Reviews of deviations.
  • Approves and closes notes to file and minor deviations
  • Execute required transactions in electronic systems (SAP)
  • Maintains investigation databases
  • Attends investigation meetings as the QA expert
  • Contributes to periodic trend analysis reports generation.
  • Contributes to the periodic report of performance indicator reports generation and to issues recommendations as required
  • Keep up to date deviations management procedures.
Skills, knowledge & Abilities
  • Strong analytical skills and ability to summarize vast amounts of data
  • Technical writing skills
  • Problem-solving skills
  • Planning and organizational skills
  • Values collaboration and team spirit
  • Facility to interact and excellent aptitude to communicate with people
  • Certification would be an asset
  • Competent with MS Office, SAP would be an asset
  • Excellent knowledge of laboratory and pharmaceutical manufacturing operations


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