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Location

Mississauga, ON | Canada

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Job description

Location: Mississauga, ON
Date Posted: 3/7/2024
Job Number: JO-2403-1679

Bora Pharmaceuticals is focused on developing and manufacturing branded, generic and over the counter (OTC) healthcare and pharmaceutical products for patients around the globe. At Bora Pharmaceuticals, we see it as our mission and our duty to make our mutual success more certain. As an ambitious, future-focused company, we know better than most that our own success is shaped by our partners victories. At Bora, we insist on high quality, reliability, and efficiency without any compromises. Dedication to these high standards is how we create a long-lasting company culture that is the bedrock for our growth

We cover the entire pharmaceutical supply chain from research and development to sales and distribution. We focus on manufacturing and selling generic, brand, and over-the-counter (OTC) drugs to clients around the world

Why join Bora?

• Competitive salary
• A modern and state-of-the-art facility
• An on-site cafeteria with dedicated chefs
• On-site gym and basketball court

Click here for a video tour of our Mississauga facility:
POSITION DESCRIPTION

TITLE : Technical- Stability Coordinator
DEPARTMENT: IDTS
POSITION REPORTING TO : Technical Manager
OPENINGS: 1

THIS IS A FULL TIME CONTRACT POSITION

General Description:

Responsible for managing all aspects of the stability program across all projects in IDTS, including managing stability studies, protocol development and maintenance, stability inventory and compiling stability reports

Responsibilities:

• Actively manage the development stability studies including the study execution and stability sample inventory for BPSI Mississauga manufactured and packaged products
• Participate in project meetings to support the stability needs for the customers
• Authoring of stability protocols and maintenance / adherence to the stability pull-schedule
• Prioritize activities and liaise with IDTS Analytical team to ensure the delivery and completion of stability timepoint testing for each product as per the protocol test schedule
• Create stability pull lists for each month and track timely completion of all stability projects
• Upon completion of timepoint testing, collaborate with IDTS Technical Process Leads to perform stability data review and trending of data over the shelf-life of the products
• Compile analytical data and generate stability reports according to agreed schedule/due date for the customers
• Assist laboratory management with investigations related to stability studies
• Ensure remaining samples from completed stability studies are appropriately disposed as per local procedures

Qualifications:

Experience and Skills

• Excellent organization and leadership skills
• In-depth understanding of cGMP, ICH and FDA stability guideline Template Version 03 May 2023 Page 2 of 2
• Excellent scientific writing and oral communication skills
• Good overall knowledge of pharmaceutical business operations
• A team player and capable to work across all levels and functions

Education
Required:

• University degree in Life Science or equivalent with minimum of 5+ years’ experience of pharmaceutical experiences Preferred:

Preferred:

• BSc in Chemistry or equivalent with minimum of 5+ years’ experience in the pharmaceutical industry

WORKING CONDITIONS
Use of PPE to prevent exposure to hazardous materials

Bora is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. Bora is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at . Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

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Job tags

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Salary