Specialist/Project Manager, quality assurance

Brief description of the position :

In order to meet the needs of its clients in the (Bio)Pharmaceutical sector, FOP CONSULTANTS is looking for quality assurance consultants to carry out various mandates. The main missions would be to review and approve the quality documents (SOP, protocols, etc.), collaborate on client’s complaints, write nonconformity, investigation, changing control and CAPA reports, present performance indicators and carry out all quality assurance tasks related to pharmaceutical products.

Main responsibilities :

Without limitation, the main tasks involve:

• Manage project related to process and documentation of quality assurance;
• Review and write quality documents (SOP, protocols, instructions, etc.);
• Document client’s complaints and ensure investigations are launched in order to resolve them;
• Provide the data of KPI in order to evaluate the company performance;
• Act as a support in order to answer to the quality of pharmaceutical products;
• Proceed to regulatory surveillance to inquire about GMP related to pharmaceutical products;
• Collaborate with teams from every department in order to resolve quality issues related to differences, changing control, CAPA and investigations;
• Participate to any enhancement project of the quality assurance system;
• Participate to the weekly or monthly meetings on quality assurance cases;
• Provide solutions to problems encountered and perform all tasks relevant to the mandate.

Qualifications :

• Bachelor's or master's degree in science (chemistry, biochemistry, biology, pharmaceutical, pharmacovigilance, etc.), or any other related discipline;
• 1 (one) to 10 (ten) years of industry experience, preferably in the (bio)pharmaceutical sector;
• Project management (an asset);
• Experience in quality assurance in the pharmaceutical field;
• Knowledge of regulations (Health Canada, FDA);
• Excellent skills in MS Office Suite;
• Good communication and writing skills in French and English;
• Mobility (an asset).

Personal skills :

• Leadership;
• Rigor et discipline;
• (Organize), able to manage several projects;
• Analytical and critical mindset;
• Perseverance;
• Humility.

What we offer :

In order to allow the full development of our team members, FOP CONSULTANTS guarantee the support and comfort necessary for the achievement of their mandate. The main advantages offered are as follows:

• Competitive wages;
• Group insurance;
• Professional insurance;
• Remote work, according to the customer needs;
• Vacations: 3 weeks;
• Paid sick leave: 3 days;
• Monthly transportation fees;
• Career advancement opportunity;
• Continuing education.