Computer Systems Validation Associate

Pharma Medica Research is a full service Contract Research Organization specialized in conducting early phase clinical trials in healthy volunteers, special and patient populations. We are always looking for top talent to join our amazing team! Currently we are looking for a Computer System Validation (CSV) Associate to join our team!

The Computer System Validation Associate I is responsible for performing Pharma Medica Research Inc. (PMRI) computer system validation (CSV) activities as well as FDA 21 CFR Part 11 initiatives. The Computer System Validation Associate I reports to the Manager, QACA and/or designate

Duties and Responsibilities:

Validate new and existing computerized systems for compliance with company SOPs, validation program, and related regulatory requirements.

Create and maintain validation documentation (i.e. validation plan, DQ, IQ, OQ, PQ, reports).

Perform revalidation procedures.

Perform GxP Computer System Change Control procedures.

GxP system administration.

Develop User Requirements, Test Cases, and Traceability Matrix.

Perform GxP and Risk Assessments.

Assist Senior CSV personnel in the implementation and maintenance of FDA 21 CFR Part 11 and related validation and regulatory requirement activities.

Other duties as required.

Qualifications:

General understanding of FDA 21 CFR Part 11 and validation principles to be effective in this position

Knowledge of current with applicable (FDA, Health Canada, EU) regulations and guidelines

Have the ability to organize and work independently and work effectively both independently and as a team member

Ability to work effectively with the other (i.e., IT, clinic, laboratory, QA) personnel

Post secondary education in a related discipline

3+ years working experience in a related field (i.e., pharmaceutical)

Excellent communication skills including excellent English verbal and written skills

Exceptional organizational skills

We offer:

Competitive compensation plan

Mentorship Opportunities

A benefit plan that is fully paid for by PMRI, including healthcare, dentalcare, vision care, LTD, Life Insurance, AD&D, along with a Health Spending and Wellness Spending Accounts and a voluntary RRSP Contribution Plan

Opportunities for advancement and career progression

A generous Employee Milestones Awards Program

Corporate Discounts Program

Friendly atmosphere, culture of learning

Please note all applications must be eligible to work within Canada.

PMRI is an Equal Opportunity Employer; promoting accessibility and inclusivity at work and offering accommodation for applicants as required and requested.