Computer Systems Validation Analyst III

Your New Company
At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them.  No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences.

We are better together and together We Are Altasciences.

About The Role
Reporting to the Manager, CSV, the Validation Analyst III will assure that equipment and computer systems are validated in accordance with industry best practices (GAMP), regulatory requirements, company policies and procedural operating standards. As a mid-level subject matter expert (SME) in Computerized System Validation, the Validation Analyst III will provide technical expertise and guidance to management and cross functions. The Validation Analyst III will assist the validation of new systems as well as changes to existing systems, and will work closely with cross functions (laboratory, production, quality) to ensure that requirements are met. The Validation Analyst III will be able to work independently on nearly all aspects of the CSV process with minimal supervision by the Manager of CSV and/or other senior members of the CSV Validation group. The Validation Analyst III is responsible for managing and leading all aspects of a CSV project towards a successful GxP compliant operational delivery and implementation. The Validation Analyst III is responsible for ensuring and developing appropriate mitigations as required to ensure the compliance of software systems.

What You'll Do Here

• Author, execute, monitor and/or review Validation documents such as: Risk Assessments, Validation Plans, Test Scripts (IQ/OQ/PQ), Traceability Matrix, and Validation Reports per Standard Operating Procedures (SOPs).

• Work closely with internally assigned departments and externally with software vendors and/or contractors, regulatory audit teams and other service providers to facilitate implementation, testing and application of validation principles throughout the implementation process.

• Train interdepartmental teams on basic GDP compliance with respect to CSV practices.

• Demonstrate mid-level technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGXP, CFR 21 Parts, 11, 210 and 211, EU Annex 11, ICH Q7, Q8 and Q9, and other applicable regulations, procedures and industry guidance.

• Ensure adherence to change management procedures for validated systems.

• Conduct technical assessments (e.g., Periodic Review) for validation compliance and impact.

• As applicable, maintain inventories, lists, status, and other tracking tools of approved validation documentation, system configuration, and change control.

• Possess and understand the key aspects of IT including: networking, LAN, WAN, Computers (servers and workstations) as well as several COTS software systems.

• Contribute to the development and maintenance of the validation quality management system (e.g., Master Plan, CSV SOPs).

• Respond to internal/external audit findings and contribute to corrective actions as needed.

• Participate in client audits and/or Quality Assurance Department activities during regulatory CSV internal/external audits

• Present and support the validation quality management system towards clients and agencies, as required.

• Coordinates activities between ITOPS and Development to ensure CSV project delivery

• Can design, develop and implement workarounds to software or process compliance failures

• Understands laboratory workflows and adapts software as well as processes for GxP compliant operation for several pharmaceutical/CRO software systems.

What You'll Need to Succeed

• Bachelor's degree in IT, Science, or related field

• 5 years experience in computerized system validation in a regulated environment

• Knowledge of MS Office suite and software testing tools (Rational Visual test)

• Basic knowledge of software development SDLC design standards and standard testing.

• Wide knowledge in COTS software systems used in Pharmaceutical/CRO industry with equivalent Laboratory process and systems knowledge.

• English (written and spoken)

Altasciences strives to provide a French work environment for its employees in Quebec. Altasciences has taken all reasonable measures to avoid imposing the above language requirement. This requirement is essential for the position of Validation Analyst III​​, in particular, but without limitation, for the following reason(s):

• The requirement to have study protocols, designs and clinical research documents written and documented in English as required by industry regulatory agencies.

What We Offer 

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences' Benefits Package Includes:

• Health/Dental/Vision Insurance Plans

• 401(k)/RRSP with Employer Match

• Paid Vacation and Holidays

• Paid Sick and Bereavement Leave

• Employee Assistance & Telehealth Programs

• Telework when applicable

Altasciences' Incentive Programs Include:

• Training & Development Programs

• Employee Referral Bonus Program

• Annual Performance Reviews

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MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH

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