Associate Stability

Associate Stability

Job Overview

Location
Brampton, Ontario
Job Type
Full Time Job
Job ID
105219
Date Posted
1 year ago
Recruiter
George Melissa
Job Views
459

Job Description

Our Brampton location is presently looking for an Associate, Stability (QA) to join our team.

The main responsibility of this position is to support routine stability administration and prepare technical reports to support Annual Stability Reviews in compliance with Taro SOP’s, Health Canada and FDA requirements. This position acts as an active influence towards elevating the quality practices and guidelines for manufactured and packaged product at the Taro facility.

Principal Duties and Responsibilities :

  • Maintenance of stability chambers- daily checks coordinates Preventative Maintenance and Calibration of these chambers.
  • Maintain stability samples inventory and responsible for daily sample pulls from the Stability Chamber and delivering to QC lab.
  • Preparation of stability protocols, updating LIMS with protocol and obtain review and approval.
  • Preparation of monthly sample Pull list and adherence to published schedule.
  • Preparation of Annual Stability commitment list.
  • Initiation of stability studies in Stability database
  • Initiate sample disposal after completion of studies
  • Compile and/or review stability data in tabulated and graphical representations and assess product stability attributes. Ensures stability data available for stability summary reports meet established specifications and deviations are investigated
  • Prepares graphical presentations of stability data
  • Verifies the correctness and validity of sample information/testing requirements entered into the stability database during stability initiations
  • Verifies the correctness and validity of sample information in creation of monthly stability pull lists
  • Prepare Annual Stability Summary reports for Regulatory Submissions
  • Initiate Change Controls and/or CAPAs as required as a result of the annual stability review.
  • Other duties as assigned.

Other Duties and Responsibilities:

  • Retrieve data from various sources (Change Controls, investigations, rejects, complaints etc.) both electronic and hard copy.
  • Prepare reports and spreadsheets in standardized formats.
  • Archival of stability documents (Initiation packages, COAs etc.)

Knowledge, Skills and Abilities

  • BSc in Chemistry
  • Minimum 2 years of experience with the Pharmaceutical industry combined with knowledge of compliance requirements for the pharmaceutical industry.
  • Strong technical writing ability in a scientific discipline.
  • Ability to analyze data utilizing statistical data software preferred
  • Proficiency with applicable computer software (Word, Excel)
  • Ability to communicate and work effectively in a team-based environment combined with good written and oral communication skills.
  • Strong organizational and multi-tasking ability in order to accommodate changes in priorities.

We thank all applicants, but only those selected for further consideration will be contacted. No phone calls please.

This position is open to applicants legally authorized to work in Canada.

Taro Pharmaceuticals embraces diversity in the workplace and is committed to achieving employment equity. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We ensure that our recruitment practices are supportive of this commitment and do not infringe on any characteristics protected by law.

In accordance with the Accessibility for Ontarians with Disabilities Act, 2005, and the Ontario Human Rights Code, Taro Pharmaceuticals will provide accommodation throughout the recruitment and selection process to applicants with disabilities. If selected to participate in the recruitment and selection process, please inform Human Resources of the nature of accommodation(s) that you may require in respect of any materials or processes used to ensure your equal participation.

Job ID: 105219

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