POSITION DESCRIPTION

FOP CONSULTANTS is looking for Technical Writers at the intermediate level motivated to deliver on mandates for its clients in the pharmaceutical and biopharmaceutical sector. The mandate is to draft and review GMP and technical documentation (SOPs, protocols, reports) in accordance with good documentation practices and to gather information from experts, manage versions and ensure the clarity, consistency and compliance of documents.

KEY RESPONSIBILITIES

- Draft procedures (SOPs), work instructions and GMP documents.
- Review protocols, validation reports and technical documents.
- Structure documentation in accordance with good documentation practices (GDP) and ALCOA+.
- Gather information from technical experts and operations.
- Manage versions, revisions and approvals in the document management system.
- Adapt content to users and translate as needed (French/English).
- Ensure terminological consistency and regulatory compliance of documents

CANDIDATE PROFILE

- Bachelor’s or Master’s degree in science, administration, literature, language or any other related discipline.
- Five (05) to ten (10) years of industry experience.
- Three (03) to seven (07) years of experience as a Technical Writer.
- Sector standards: GMP (Health Canada),



FDA 21 CFR 210-211, ICH Q7 to Q10, GAMP 5, ISO 9001.
- Tools and systems: MS Office suite, Adobe FrameMaker, MadCap Flare, Visio, Veeva Vault.
- Hold one of the following certifications: Technical writing certification, AMWA, GMP.
- The following are considered assets: RAC (RAPS), ASQ CQA, document management certification.
- Experience in Canadian public or private organizations.
- Language: French and English

WORK MODE

- Remote, Hybrid, In office

WHAT WE OFFER

At FOP CONSULTANTS, we invest in the success and well-being of our experts. By joining our team, you benefit from an environment designed to support your performance and respect your work-life balance, including:

- Competitive compensation that reflects your expertise;
- Complete protection through our group insurance plans;
- Professional liability insurance so you can practise with confidence;
- Remote-work flexibility, based on client needs;
- 3 weeks of vacation to recharge;
- 3 paid sick days, to take care of yourself;
- A monthly allowance for your transportation costs;
- Real opportunities for advancement within the organization;
- Ongoing access to training to grow your skills.

📌 Technical Writers (Int.) (Quebec City)
🏢 FOP Experts Conseils
📍 Quebec City