Specialist - Computer System ValidationJubilant Pharma, LLC • Montreal, Montreal (administrative region), CA

Specialist - Computer System Validation

Jubilant Pharma, LLC • Montreal, Montreal (administrative region), CA

Il y a plus de 30 jours

Type de contrat

Temps plein

Description de poste

JOB DESCRIPTION

At Jubilant Radiopharma , we’re advancing healthcare through innovation in radiopharmaceuticals. As a Specialist in CSV, IT & Data Governance , you’ll play a critical role in ensuring our digital systems meet the highest standards of regulatory compliance, data integrity, and operational excellence. This is your opportunity to be a trusted SME, lead cross‑functional initiatives, and directly influence regulatory readiness across our IT landscape.

What You’ll Do

Lead CSV & Data Governance Strategy

Own and execute the site-level Computer System Validation (CSV) Master Plan .

Develop and maintain robust policies and SOPs aligned with :

FDA 21 CFR Part 11

Health Canada GUI‑001

EU Annex 11

GAMP5 , PIC / S , and other global regulatory frameworks.

Champion data integrity and governance best practices across the organization.

Drive IT Compliance & Lifecycle Management

Oversee compliance of IT systems and applications , including backup, archival, and user access management.

Lead change control processes and periodic system requalification activities.

Ensure systems remain in a validated state throughout their lifecycle.

Be the SME in Audits & Inspections

Represent Jubilant as the Subject Matter Expert during regulatory inspections and client audits .

Articulate and defend CSV and data governance strategies, policies, and procedures with confidence and clarity.

Collaborate Across Functions

Partner with IT, QA, Engineering, and Supply Chain to ensure seamless integration of compliance into operations.

Coordinate with vendors to ensure third‑party systems meet internal and regulatory expectations.

Lead Risk Assessments & Compliance Reviews

Facilitate and lead 21 CFR Part 11 risk assessments , including SLRA and FLRA.

Support investigations and CAPAs related to IT systems and data compliance.

What You Bring

Bachelor’s or Master’s degree in Computer Science, Biotechnology, IT, or a related field.

5–8 years of hands‑on experience in CSV, IT compliance, and data governance within a regulated pharmaceutical or life sciences environment.

Proven experience supporting regulatory inspections and client audits .

Deep knowledge of global regulatory requirements (FDA, EU, Health Canada, GAMP5, PIC / S).

Strong analytical, documentation, and problem‑solving skills .

Bilingualism (French / English) as the role interacts with regulatory agencies based outside Quebec.

A collaborative mindset with the ability to lead cross‑functional teams and influence without authority.

Why Join Jubilant Radiopharma?

Be part of a mission‑driven organization improving patient outcomes through nuclear medicine.

Work in a high‑impact role with visibility across departments and leadership.

Enjoy a collaborative culture , continuous learning, and opportunities for career growth.

Ready to shape the future of compliance in radiopharma? Apply now and bring your expertise to a team that values innovation, integrity, and excellence.

#J-18808-Ljbffr

Créer une alerte emploi pour cette recherche

Validation Specialist • Montreal, Montreal (administrative region), CA

Offres similaires

Physics Private Tutoring Jobs Saint-Jacques

Superprof • Saint-Jacques, Canada

Temps plein +1

Superprof is Canada's #1 tutoring platform, and we're actively recruiting passionate tutors! Whether you're a student, a professional, or simply someone who loves teaching, join the largest communi...Voir plus

Dernière mise à jour : il y a plus de 30 jours • Offre sponsorisée

Software Support Specialist [#4893]

Alteo • Montreal, QC, Canada

Permanent

Alteo is looking for a Software Support Specialist for a permanent position based in Montreal.Hybrid work : 2 days in the office / week • • •. Respond to user calls and emails (technical or software trai...Voir plus

Dernière mise à jour : il y a 3 jours • Offre sponsorisée

Senior Technology Systems Designer

H.H. Angus and Associates Limited • Montreal, QC, Canada

Temps plein

At HH Angus, we strive to expand what is possible to shape a better future.We do this by empowering our employees to do their best work, find meaning in what they do and provide opportunities to gr...Voir plus

Dernière mise à jour : il y a 28 jours • Offre sponsorisée

Information Technology Support Specialist / Spcialiste de l'assistance informatique

Digital Days • Montreal, QC, Canada

Temps plein

Information Technology Support Specialist.At Digital Days, an IT Support Specialist is responsible for managing their ticket queue and interfacing directly with end-users to help resolve their IT i...Voir plus

Dernière mise à jour : il y a plus de 30 jours • Offre sponsorisée

Computerized Systems Validation Specialist

GenAIz • Montreal, QC, Canada

Temps plein +1

Le Groupe Uni3T est une socit informatique jeune et dynamique qui est active dans les secteurs des sciences de la vie et de l'industrie pharmaceutique. L'entreprise est ne d'une volont d...Voir plus

Dernière mise à jour : il y a plus de 30 jours • Offre sponsorisée

Senior Systems Engineer

Targeted Talent • Montreal, QC, Canada

Temps plein

The Systems Engineer will provide hands-on experience in design and engineering efforts implementing DevOps Platforms, common set of products and services used across development and infrastructure...Voir plus

Dernière mise à jour : il y a plus de 30 jours • Offre sponsorisée

Spécialiste en ingénierie des systèmes d'appel d'offres / Bid System Engineering Specialist

ISC Applied Systems Corp ~ The Passenger Experience • montréal (pointe-claire), montréal (pointe-claire), ca

Temps plein

ISC Applied Systems est une entreprise canadienne spécialisée dans le domaine des systèmes d'information et de sécurité pour les trains de voyageurs depuis plus de quarante (40) ans.Nous développon...Voir plus

Dernière mise à jour : il y a plus de 30 jours • Offre sponsorisée

Technical Support Engineer - Haivision

Haivision • montréal, qc, ca

Temps plein

Proficiency in Spanish (written and verbal) is mandatory.The Technical Support Engineer will combine technical expertise with a customer-focused approach to ensure an outstanding post-sale customer...Voir plus

Dernière mise à jour : il y a plus de 30 jours • Offre sponsorisée

Technician, store system support TAMS

UAP Inc. • Montreal, QC, Canada

Temps plein

At UAP, our vast team of tech enthusiasts is dedicated to driving efficiency, reliability and excellence in every aspect of&nbs...Voir plus

Dernière mise à jour : il y a plus de 30 jours • Offre sponsorisée

Technical Support Trainer

Mircom Group of Companies • Pointe-Claire, QC, Canada

Temps plein +1

Centre of Excellence - Technical Support Trainer.Founded in 1991, the Mircom Group of Companies is North America’s largest independent designer, manufacturer and distributor of intelligent bu...Voir plus

Dernière mise à jour : il y a plus de 30 jours • Offre sponsorisée

Senior System Safety Engineer

CS GROUP • Montreal, QC, Canada

Temps plein +1

CS Group Canada, a subsidiary of CS Group (part of the Sopra Steria Group), is a leader in the development and certification of safety-critical systems in the aerospace, electric, and autonomous dr...Voir plus

Dernière mise à jour : il y a 22 jours • Offre sponsorisée

Senior Entra ID System Administrator - Contract

Itergy • Montreal, QC, Canada

Temporaire

Senior Entra ID System Administrator - Contract.Location : Montreal, Qubec (Hybrid / Remote).Type : 12-Month contract with the possibility of extension. Senior Entra ID System Administrator.We are seeking...Voir plus

Dernière mise à jour : il y a 2 jours • Offre sponsorisée

QA Analyst - Systems

Loc Software • Laval, QC, Canada

Temps plein

If you aspire to participate in the growth of a company proudly Canadian while developing your abilities and where your ideas will be heard, LOC Software is the employer for you!.We are the premier...Voir plus

Dernière mise à jour : il y a plus de 30 jours • Offre sponsorisée

IT Systems & Infrastructure Specialist

Anyon Systems Inc. • Dorval, QC, Canada

Temps plein

Anyon Systems is a Canadian quantum computing company based in Montreal, QC, dedicated to building the most advanced quantum processors in the world. Our multidisciplinary teamspanning physics, nano...Voir plus

Dernière mise à jour : il y a 15 jours • Offre sponsorisée

Training Specialist - Set 2 Close | B Corp

Set 2 Close | B Corp • saint-esprit, qc, ca

Temps plein

Training Specialist / Consultant.We specialize in integrating platforms like HubSpot to supercharge lead generation, marketing automation, sales enablement, and customer success.Join us to drive tran...Voir plus

Dernière mise à jour : il y a plus de 30 jours • Offre sponsorisée

Spécialiste des Systèmes - Compétitivité / Systems Competitiveness Specialist

Airbus Canada Limited Partnership • Mount Royal, QC, Canada

Permanent

English job description follows.Airbus Canada est à la recherche dun.Spécialiste des Systèmes hautement motivé et expérimenté pour se joindre à lorganisation de lIngénieur en Chef de lA220.Relevant...Voir plus

Dernière mise à jour : il y a 7 heures • Offre sponsorisée • Nouvelle offre

AI Systems Developer

dcbel Inc • Montreal, QC, Canada

Temps plein

Our flagship product, the dcbel Home Energy Station, is a small wall mounted device that gives everyone ownership over their energy supply by using solar power to charge their EV and home, unlockin...Voir plus

Dernière mise à jour : il y a plus de 30 jours • Offre sponsorisée

Metalworking Specialist

Walter Surface Technologies Incorporated • Pointe-Claire, QC, Canada

Temps plein

For over 70 years, Walter Surface Technologies has been a global leader in surface treatment technologies delivering high performance abrasives, tooling, power tools, chemical solutions and welding...Voir plus

Dernière mise à jour : il y a 9 jours • Offre sponsorisée