Spécialiste sénior, assurance qualité, conformité et validation

LAPORTE L.E.C.•Quebec, QC

19h•Hybrid

About The Position

LAPORTE is a consulting engineering firm offering high-value engineering services to pharmaceutical, agri-food, and industrial biotech plants. The company currently has 25 offices across North America and Europe, and brings together over 480 passionate engineering employees. We offer a stimulating environment where autonomy, collaboration, and professional growth are at the heart of our daily lives. We believe in a flexible work framework that values work-life balance while encouraging efficiency and creativity on a daily basis. Discover an employer who takes care of its greatest asset: its employees! LAPORTE is looking for a senior specialist in quality assurance, compliance, and validation with 7 to 10 years of experience to join its Quebec team, with offices located in Sainte-Foy. The selected person will act as a consultant to LAPORTE Experts-Conseils clients. They will intervene directly on client sites to plan, execute, and document quality assurance and validation activities while ensuring their compliance with applicable regulatory requirements.

Requirements

Bachelor's degree in science or engineering
7 to 10 years of relevant experience in a regulated pharmaceutical industry
Excellent knowledge of Health Canada, FDA, EMA
Ability to manage multiple mandates in parallel in varied client environments
Solution-oriented and pragmatic approach
Technical leadership and professional credibility with clients
Adaptability and professional judgment in a regulated context
Excellent written and verbal communication skills

Nice To Haves

Member of the Ordre des ingénieur.es du Québec (an asset)

Responsibilities

Act as a quality expert with clients for complex compliance issues
Assess the compliance status of systems, equipment, and processes
Write or revise quality procedures (SOP)
Perform critical review of validation and change control files
Support clients during audit findings and for the writing of regulatory responses
Contribute to the continuous improvement of client quality systems
Train client teams on GMP requirements and good validation practices
Advise clients on the interpretation of regulatory requirements
Plan qualification activities in collaboration with client teams (engineering, maintenance, production, QA)
Prepare and revise IQ, OQ, and PQ protocols according to internal and regulatory standards
Supervise and support junior resources during on-site validation activities
Review technical drawings, specifications, and P&IDs before qualification
Verify traceability between requirements, executed tests, and obtained results
Ensure the compliance of tests performed with procedures and good documentation practices
Participate in the resolution of technical problems in the field
Recommend corrective or preventive actions related to observed deviations
Evaluate the categorization and criticality of computerized systems (GxP)
Define risk-based validation strategies
Write or support the writing of traceability matrices
Review system configurations and critical parameters
Support data integrity tests (Data Integrity – ALCOA+)
Evaluate the compliance of suppliers and solutions (COTS, SaaS, infrastructure)
Provide support during system updates, migrations, or decommissioning
Participate in the impact analysis of computerized changes

Benefits

Opportunities for rapid advancement
Hybrid work model, minimum 2 days per week in the office
An environment that promotes accountability and professional growth
Comprehensive group insurance with coverage from the 1st day of employment (medical, dental, vision)
3 weeks of regular vacation from your hiring
+1 week of vacation at Christmas, closed and paid
+1 additional week of personal leave
Employer contribution to RRSP pension plan of 4%
OIQ fees paid by Laporte
Reimbursement of public transport costs
Electric vehicle charging stations