Data Reviewer - Day Shift
PharmascienceMontréal, QC, CA30+ days ago
Job type
- Full-time
Job descriptionB.Sc. in chemistry or biochemistry or equivalent experience 3 to 5 years in pharmaceutical laboratory Bilingual as the incumbent will be reviewing information in French and English for suppliers and clients located outside of the province of Quebec Extremely well organized & detail oriented Excellent interpersonal communication skills (computer, written & verbal) Good working knowledge of GMP’s and GLP’s Hands on expertise with LC / MS / MS and various wet chemistry techniques Familiar with Analyst, DMS Open Text and Trackwise software.
Under minimal supervision, performing detailed and timely review of chemistry raw data and results generated during Q.C. testing of raw material, and finished products for the testing of nitrosamine impurities and ensure that all produced data and results are in accordance with methods, specifications, SOP’s, Good Laboratory Practices and Good Manufacturing Practices.
Responsibilities & Duties :
- Verifying all laboratory documents such as laboratory notebooks, laboratory result sheets and calculation worksheets that are generated by the bioanalytical laboratory.
- Verifying all laboratory results ensuring accuracy, integrity and traceability of supporting raw data are produced in accordance with GLP, testing method and standard operating procedure.
- Assist managers during investigations of OOS results and consult the department manager regarding omission, deviation, incomplete results and other irregularities.
- Review and approval of documentations and data related to analysis of impurities by LC-MS / MS of GMP samples
Skills, Knowledge & Abilities :