Quality and Compliance Specialist - Stability

Join the Halo Pharma Adventure: Together, Let's Make an Impact!

At Halo Pharma, we are an ambitious company determined to make a difference for our clients! In our dynamic and friendly work environment, the atmosphere is both respectful and stimulating. Here, every contribution matters, and we firmly believe that success is built together.

Humanity is at the heart of our corporate culture. We understand that life is not limited to work, which is why we offer schedules that promote a balance between professional and personal life. You will thus be able to flourish both professionally and personally.

Our daily routine is driven by active collaboration and a pursuit of excellence. Every member of our team is committed to contributing their share, sharing innovative ideas, and working together to achieve our common goals. If you are passionate and determined to move things forward, you are in the right place!

We also take pride in offering development opportunities. If you are curious and eager to learn, you will find here resources and projects that will allow you to grow. And let's not forget our social activities, which are the perfect opportunity to build relationships and celebrate our successes together.

So, are you ready to join a team where you can not only contribute but also grow and flourish? Together, let's make a difference and create a promising future!

The Quality and Compliance Specialist is responsible for verifying compliance with Good Manufacturing Practices (GMP) according to the various competencies listed below. The specialist may be responsible for activities related to one of the competencies, or a combination of several competencies.

Competency 1 – Documentation

• Review and approve the SOPs (Standard Operating Procedures) of the various departments of the site (Engineering, IT, Validation, Laboratories and Technical Services, Production, Distribution and Supply Chain) following their creation and/or modification.
• Ensure that all relevant documentation is attached to the change request and that the directives described in the SOP are compliant with GMP.
• Verify the CAPA’s associated with the update of the SOPs

Competency 4 – Document Review

• Document review of the folders of finished products, raw materials, packaging components and related documentation.
• Ensure that all documentation is available, complete and request corrections as needed.
• Proceed to the disposition of products, ensure the consistency of quantities and dates of re-analysis or expiration.

Competency 5 – Stability

• Manage stability studies for products in development and commercial products
• Create stability protocols
• Write stability reports
• Collect samples and place them in the appropriate stability conditions.
• For commercial products: evaluate the production schedule, select and collect samples for annual stability.
• Ship samples to laboratories for analysis as required by the protocols.
• Investigate out-of-spec or unexpected results.

Requirements

• Education: DEC or BACC in sciences or equivalent diploma.
• Experience: Min 5 years of experience in quality assurance in the pharmaceutical industry.
• Other (knowledge, skills, etc.)

In-depth knowledge of Good Manufacturing Practices and Canadian and American regulations.

Excellent knowledge of French and English, both written and oral (bilingual).

Practical knowledge of Microsoft software such as Word and Excel

Knowledge of SAP, Master Control, Labware and TrackWise systems is an asset.