Benefits
- Commitment to work-life balance
- Disability insurance
- Floating leave days
- Insurance
- On-going training
- Paid leave
- Paid sick leave
- Performance bonuses
- Reimbursement for public transportation
New
Telecommuting
specialists in quality assurance (Sr.)
FOP Experts Conseils inc.
202-9420 Boulevard Taschereau, Brossard,QC- Salary To be discussed
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37.50 to 40.0 h - Full time
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Contract ,Permanent ,Telecommuting job
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Day shift work
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3 positions to fill as soon as possible
Description
POSITION DESCRIPTION
CANDIDATE PROFILE
WORK MODE
WHAT WE OFFER
Read more
FOP CONSULTANTS is looking for specialists in quality assurance at the senior level motivated to deliver on mandates for its clients in the pharmaceutical and biopharmaceutical sector. The mandate is to maintain the pharmaceutical quality system in compliance with GMP and ICH Q10 and to approve GMP documentation, manage deviations, CAPA and changes, conduct audits and support regulatory inspections. The senior scope is further to define the site quality strategy and compliance roadmap and to mentor intermediate consultants and review their deliverables.
KEY RESPONSIBILITIES- Maintain and improve the pharmaceutical quality management system (ICH Q10).
- Review and approve batch records, procedures and GMP documentation.
- Manage deviations, CAPA, changes and complaints.
- Conduct internal and supplier audits and follow up on findings.
- Participate in Health Canada and FDA regulatory inspections.
- Produce annual product reviews and quality indicators.
- Train personnel on GMP and data integrity.
- Define the site quality strategy and compliance roadmap.
- Mentor intermediate consultants and review their deliverables.
- Lead client and regulatory audits and their action plans.
CANDIDATE PROFILE
- Bachelor's or master's degree in science (chemistry, biochemistry, biology, pharmaceutical, pharmacovigilance, etc.), or any other related discipline.
- Minimum ten (10) years of industry experience.
- Eight (08) to fifteen (15) years of experience as a Specialist in Quality Assurance.
- Sector standards: GMP (Health Canada), FDA 21 CFR 210-211, ICH Q7 to Q10, GAMP 5, ISO 9001.
- Tools and systems: MS Office suite, TrackWise, Veeva Vault, SAP QM, Power BI.
- Hold one of the following certifications: ASQ CQA, ASQ CQE, ISO 9001 Internal Auditor.
- The following are considered assets: ASQ CMQ/OE, Six Sigma Green Belt, ISO Lead Auditor.
- Experience in Canadian public or private organizations.
- Language: French and English
WORK MODE
- Remote, Hybrid, On-site
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.
Work environment
Equal Opportunity Employer
This employer is an equal opportunity employer committed to diversity and inclusion. We are pleased to consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veterans status, Aboriginal/Native American status or any other legally-protected factors. Disability-related accommodations are available on request for candidates taking part in all aspects of the selection process.
Requirements
Level of education
University
Diploma
BAC
Completed
Work experience (years)
10+ years
Written languages
Fr : Advanced
En : Intermediate
Spoken languages
Fr : Advanced
En : Intermediate
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