Vita Health Products Inc. Validation Specialist – Method Temporary in Winnipeg, MB

Overview

Vita Health Products Inc.

Branch Winnipeg MB CA

Position:
Validation Specialist – Method
Location:
Winnipeg, MB

Knowledge of the pharmaceutical, ICH, GLP and GMP regulations; These include active pharmaceutical ingredients, excipients and finished products in various…

Position: Method Validation Specialist
18 months Term Position

Reporting to the Validation Manager, the incumbent will be required to:

• Responsible for all activities related to the development of analytical methods for pharmaceutical and Natural Health Products related products that are being developed for Vita Health Products (OTC, NHP etc.). These include active pharmaceutical ingredients, excipients and finished products in various dosage forms.
• Develop, optimize and troubleshoot methods using various equipment (HPLC, UPLC, GC, Dissolution, Titration, ICP, etc) and detectors (UV, DAD, Refractive Index, MS, FID, ELSD etc.). * Actively participate in resolution of Clarifaxes and resolve analytical challenges. * Follows up on the above activities, communicates and ensures that timelines are respected with the appropriate quality.
• Write and review Validation Protocols and generate reports.
• Review and revise Standard Test Methods and SOPs.
• Recommend new approaches to analysis of finished products, API/NHP Raw Materials Excipients and vitamins.
• Participate in method transfers, analytical investigations and projects.
• Interpret and investigate QC analysis with adequate documentation and rationale justification.
• Implement plans on how to improve existing test methods.
• Follows up on the above activities, communicates and ensures that timelines are respected with the appropriate quality.
• Flexibility in the organization and realignment of priorities while facing tight deadlines, new needs or unexpected obstacles.
• Knowledge of the pharmaceutical, ICH, GLP and GMP regulations; Able to make quick and effective decisions. Interpret and apply various international regulations.
• Depth knowledge of USP / Ph. Eur. pharmacopeias
• Sense of innovation.

Qualified candidates will have a B.Sc. with 2 to 5 years of solid, hands-on HPLC/UPLC, GC, Dissolution, ICP, IR, UV-VIS spectrophotometer, polarimeter, Karl Fischer, analytical balance, conductivity, TOC experiences as well as familiarity with wet chemistry methodologies. Experience in a QC or Validation environment in the pharmaceutical industry is a requirement. Experience with Empower, SOLABS, Change Control software would be considered an asset. Mathematical skills and/or experience with statistical software and spreadsheet programs such as Microsoft Excel are also considered assets. Candidates must have proven ability to work with precision and accuracy and be capable of performing and mastering new techniques effectively. Further, the candidates will be in a fast paced and dynamic environment and must be willing to comply with strict laboratory testing deadlines, be able to take initiative, be an independent thinker and worker as well as function exceptionally in a multi-departmental team environment. The incumbent will also possess excellent written and verbal communication skills, and be familiar with GMP guidelines.

Job Type: Temporary

Required experience:

• Method Validation: 3 years

Required education:

• Diploma/Certificate