Prepares technical documents including Specifications, Analytical Methods and Stability Protocols to be used by the QC laboratory and follows Regulatory, corporate and industry standards. Prepares Annual Product Reviews and Annual Stability Reports including compilation, and statistical trending. Assists in the investigation of Incoming Material deviations.
- Prepares technical documents and change controls including Specifications, Analytical Methods, Stability Protocols.
- Prepares Annual Product Reviews and Annual Stability Protocols.
- Attends client meetings related to regulatory filings, technical document requirements and change controls.
- Assists in Incoming Material investigations (DRs) including initiating, contacting vendors and compiling documentation.
- Other duties as assigned.
- College/Technical School diploma in Food and Drug.
- 1 to 3 years of previous related experience.
- Understanding of Regulatory requirements including USP/NF and Ph. Eur.
- Familiarity with Good Manufacturing Practices.
- Excellent computer skills in Word and Excel.
- Proficiency with the English language, both written and spoken.
- Excellent attention to detail.
- Self motivated and able to work independently.
- Experience in laboratory testing is an asset.
- Experience in Microsoft Access is an asset.
- Familiar with APRs, ASRs and Technical Documents is an asset.
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