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Stability Coordinator

2 months ago

Mississauga, Canada Bora Pharmaceutical Services Full time

**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

**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