Quality and Compliance Specialist (Temporary - 18 months)

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. This way, you can 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.
• Perform verification of CAPA’s associated with the update of SOPs

Competency 2 – Change Management

• Participate in the management of change controls at the site. Prepare the change control committee meeting, analyze the impact, create and verify the associated actions.
• Create specifications for finished products, raw materials and packaging components according to the current monograph and/or client requirements.
• Keep the BBF fields of Master Data up to date such as product status and expiration date.

Competency 7 – Controlled Substances Management

• Keep up to date and make modifications to the various licenses of controlled substances (narcotics, precursors, alcohol),
• Submit requests and reports to the government agencies, such as sales reports, losses, use, importation, exportation.
• Manage the inventory of controlled substances from receipt to destruction.
• Ensure that substances are located according to procedures and ensure that monthly inventory is done.
• Keep records up to date and verify transactions made for these substances.
• Control access and security measures for access to controlled substances;
• Prepare transfer requests and perform necessary checks during the reception and shipment of controlled substances.

Competency 9 – Compliance and Regulatory

• Compile data, analyze the performance of the site's quality systems (such as water, air, environment, deviation, complaint) and generate annual reports.
• Compile data and proceed with the annual review of products and/or associated sub-reports.
• Identify and evaluate changes in Pharmacopoeias.
• Support regulatory and client audits from a logistical perspective (room reservation, basic documentation, meals...), reception and communication of requests, entry and exit of requested documents. Communicate the progress of the audit and the needs of support to the various internal departments

Requirements

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

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

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

Practical knowledge of Microsoft software such as Word and Excel

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