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Validation Specialist

3 weeks ago

Laval, Canada Altasciences Full time

Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.

The Validation Specialist must possess and understand the key aspects of IT including: networking, LAN, WAN, Computers (servers and workstations) as well as several COTS software systems. The Validation Specialist is responsible for managing and leading all aspects of a CSV project towards a successful GxP compliant operational delivery and implementation including appropriate mitigations, as required. The Validation Specialist will also create or assist in the creation of appropriate Validation procedures and forms.

The Validation Specialist is expected to be a Subject Matter Expert in the operation of the corporate electronic validation software platform. The Validation Specialist can act as the designated backup for the CSV Validation Manager, as needed.

Main Responsibilities
- Lead the team in the implementation and use of the corporate electronic validation software
- Lead team members in the definition and execution of the elements required for the successful validation of COTS software or internally developed systems according to industry standards (e.g. FDA, TPD)
- Lead team members and users in the compilation and assist in the development of the functional and specific user needs based on the GxP use of software/system and in accordance with the risk assessment
- Assess the compliance of systems with FDA 21 CFR part 11 and EU Annex 11 and ensure adequate mitigation strategies are put in place as required
- Lead the team and the users in the development and execution of test scenarios (Tests Scripts, User Acceptance Tests, etc) and test reporting documentation as per CSV/GAMP5 models
- Ensure the availability of computer systems validation documentation to support audit requirements
- Ensure and lead the coordination of activities between ITOPS, Development and the users as required for Computer Systems Validation
- Autonomous in the management of CSV projects towards a successful GxP compliant operational delivery
- Will ensure the design, development and implementation of mitigation strategies for software or process compliance issues
- Understands laboratory workflows and adapts software as well as processes for GxP an lead a multidisciplinary team in complex validation projects

Desired Profile
- College or Bachelor degree in IT or scientific fields or equivalent experience.
- 7+ years of experience in computer systems validation or software quality assurance.
- Good communication with internal and external customers.
- Sound knowledge of software development SDLC design standards and standard testing.
- Advanced knowledge of MS Office and software testing tools (Rational Visual test - would be an asset).
- IT knowledge in networking LAN, WAN, computers, servers
- Knowledge in software systems and instrumentation used in
- Pharmaceutical/CRO industry with equivalent Laboratory process and systems knowledge.
- Bilingual - French/English - written and spoken

Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences