Sr. Quality Assurance Specialist in Laval, Canada

Sr. Quality Assurance Specialist

Location: Laval, CA

Remote Work: Hybrid

Job Type: Full time

About the Job

At Sanofi Consumer Healthcare, we have one shared mission – we work passionately, every day, to ‘serve healthier, fuller lives’ now and for the generations to come.

In order to do so, we strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view.

Everything we do is centered around people’s interests – our consumers, our customers, healthcare professionals, and our employees – across the world.

We are building loved brands that serve 1bn consumers worldwide, through our key platforms: Allergy, Physical & Mental Wellness, Pain, Digestive Wellness and Cough, Cold & Flu.

We aspire to become the best Fast Moving Consumer Health (FMCH) company In & For the world and we aim to build a work environment where people can thrive, grow, enjoy and be at their best.

Position Summary

Contribute to establishing and maintaining high quality and compliance status of all products handled by Sanofi Canada to meet all Canadian cGMP regulations as well as corporate requirements.

Main Responsibilities

• Planning and coordinating daily, weekly and monthly release activities as well as other compliance related activities.

• Provide QA expertise to internal and external partners.

• Collect, review and approve all required documentation necessary for product release, including batch documentation review.

• Process product technical complaints of marketed and non-marketed products including complaint sample management.

• Follow site investigations and established corrective actions and reply to customers

• Issue reports on product technical complaints

• Review the Annual Product Review and Stability Data

• Approve artworks for printed packaging components

• Track, request, and compile documentation for the compliance status of all foreign sites, to allow the importation of products in Canada via valid Establishment License

• Issue and maintain Quality Agreements

• Response to MedInfo requests

• Coordinate specifications and methods up to date.

• Send product for testing, approve results and support laboratories if required.

• Issue Change Requests, Deviations, Investigations and CAPAs.

• Maintain retention sample program

• Perform other Quality Systems activities such as reporting of quality metrics, trend reporting, training management and document management

• Oversee the compliance with the regulations on precursors A.

• Manage all related RP activities for precursors A: renewal and modification of precursors’ license, importation/exportation permits for precursors, inventories of precursors, management of the precursors cage, procedures on precursors, Health Canada annual report for precursors, Health Canada audits on precursors, and management of precursors’ destruction.

• Support license management and inspection activities

• Training Management

• Other QA duties as assigned.

About You

Education

• B.Sc. in Chemistry, Biology or related sciences.

Experience

• 5+ years of experience in the pharmaceutical industry.

• 2+ years of experience related to importation of Canadian products.

Skills

• Knowledge of GMPs and Health Canada regulations regarding drugs, natural health products and cosmetics

• Strong Verbal and Written Communication Skills

• Problem Solving Skills

• Adept at Attention to Detail

• Strong understanding of Good Documentation Practices

• Good organizational skills

• Analytical skills

• Self-motivated/directed

• Computer literate-proficient in use of word processors. Must be able to understand and utilize complaint database software and reporting tools

• Project and Time Management Skills

• Interpersonal skills-must be proactive, personable, flexible, team-oriented

• Customer Service Skills

• Ability to multitask in a highly stressful environment

• Ability to operate in a constantly changing environment

Languages

French – Excellent knowledge

English – Excellent knowledge

Travel

Occasional (Less than 10%)

Computer Skills

SAP, MS Office, Adobe Suite

Pursue Progress, Discover Extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

#-LI-SA

#GD-SA

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.