Purpose
To analyse R&D trial batches, Stability Samples and Routine calibration of the Instruments
Position / Job Title
Lab Assistant
Department
R&D
Reporting To
R&D Manager
Location
Concord - Canada
Years of Experience
0 to 1 year in Pharma
Dosage Form
Solid/Nasal/Liquid
Job Responsibilities / Deliverables:
- To analyse Assay, Preservative content, SAC, DSD, Osmolality, Viscosity and Spray pattern testing of R&D Trial batches samples, Stability samples and Stability report preparation.
- Particulate matter method development and R&D Trial batch analysis by APSS, PSD method development by Microscope and Viscosity method development.
- Cleaning method development and partial validation.
- Partial validation of Assay, Preservative content methods.
- Reverse engineering study, Tubing study analysis, PDR batches analysis
- To perform Chemical testing and Method evaluation for API
- Daily Balance calibration, pH meter calibration, Actuator movement verification / Load cell calibration of Proveris and Malvern system.
- Development STP, Specification and Development Stability Protocol and report preparation
- Controlled substance sample destruction on weekly basis
Qualifications & Pre-Requisites:
- Master of Science Degree in a chemistry or related field, combined with minimum 0-1 year of pharmaceutical industry experience in a laboratory / GMP setting.
- Knowledge of Health Canada and U.S. FDA GMP requirements for pharmaceutical testing, the Controlled Drugs and Substances Regulations and the Precursor Control Regulations would be an asset.
- Good working knowledge of Microsoft Office programs, especially Excel and Word.
Additional notes:
- Receiving, inventorying, labeling and disposing of samples requires some reaching/bending and light lifting on a daily basis.
- Flexibility in hours of work to address emergency issues / controlled substance related activities outside of normal workday.
