Computer System Validation Assistant

Pharma Medica Research Inc.; Mississauga; On-site; CAD 42,000 - 59,000; Full time

Benefits offered by this job

Competitive compensation plan

Fully paid health and other benefits

Career advancement opportunities

Employee milestones awards

Corporate discounts program

Friendly atmosphere

Job summary

Pharma Medica Research Inc. in Mississauga is seeking a Computer System Validation Assistant to join our CSV team. You will support validation activities for computerized systems in a regulated environment and report to the Manager, CSV & Compliance.

The role emphasizes collaboration, attention to detail, and staying current with FDA/Health Canada guidelines. Ideal for candidates with post-secondary education and 0–1 year experience seeking growth in pharmaceutical validation.

Qualifications

• Post secondary education in a related discipline.
• General understanding of CSV principles and applicable regulatory requirements.
• 0–1 years of experience in a related field (pharmaceuticals preferred).
• Ability to organize and work well independently and in a team.
• Excellent English communication skills.
• Willingness to stay current with FDA, Health Canada, and EU guidelines.

Responsibilities

• Assist in Validation of new and existing computerized systems for compliance with procedures and regulatory requirements.
• Assist in Creation and maintenance of validation documentation (DQ, IQ, OQ, PQ, reports).
• Assist in Performing GxP and Risk Assessments of the computerized systems.
• Assist in Development and execution of Test Cases, Traceability Matrix, and Validation Reports.
• Assist Senior CSV personnel in implementing and maintaining validation activities.

Skills

Communication skills

Team collaboration

Attention to detail

Documentation skills

Computer literacy

Education

Post-secondary education in a related discipline

Tools

GAMP-5 Guidelines

Job description

Pharma Medica Research (PMRI) Inc. is a Contract Research Organization that strives for innovation and original solutions in a highly regulated and competitive industry. If your career goals align with innovation and original thinking you will be the perfect candidate to be part of an inclusive, adaptable, and forward-thinking organization. Our reputation for delivering high quality research is outstanding. At PMRI we are committed to making a difference in healthcare and people’s lives. We are currently looking a Computer Systems Validation Assistant to join our Mississauga team, Come join us!

The Computer System Validation Assistant i is responsible for performing Pharma Medica Research Inc. (PMRI) computer system validation (CSV) activities in accordance with established procedures, GAMP-5 Guidelines and applicable regulatory requirements. The Computer System Validation Assistant reports to the Manager, CSV & Compliance and/or designate.

Duties and Responsibilities:

• Assist in Validation of new and existing computerized systems for compliance with established procedures, validation program, and related regulatory requirements (i.e. FDA 21 CFR Part 11, EMA, GLP, GCP).
• Assist in Creation and and maintenance of validation documentation (i.e. SUR, validation plan, DQ, IQ, OQ, PQ, reports).
• Assist in Performing GxP and Risk Assessments of the computerized systems.
• Assist in Development and execution of Test Cases, Traceability Matrix, and Validation Reports.
• Assist in Performing revalidation procedures.
• Perform assigned GxP Computer System Change Control procedures.
• Assist in GxP system administration.
• Assist in Performing Periodic Reviews of Computerized systems, as applicable.
• Assist Senior CSV personnel in the implementation and maintenance of validation and regulatory requirement activities.
• Other duties as required.

Requirements:

• Post secondary education in a related discipline.
• Have a general understanding of computer system validation principles and applicable regulatory requirements.
• 0-1 years of working experience in a related field (i.e. pharmaceutical).
• Ability to organize and work effectively both independently and as a team member.
• Proficiency in computer usage and software applications.
• Excellent communication skills including excellent English verbal and written skills.
• Excellent interpersonal skills with the ability to work effectively with other departmental personnel (i.e. IT, clinic, laboratory, QA).
• Ability to communicate clearly and effectively with other staff.
• Exceptional organizational skills.
• Be willing to stay current with applicable (FDA, Health Canada, EU) regulations/guidelines.

We offer:

• Competitive compensation plan
• 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.

We thank all applicants for their interest; however, only those selected to proceed in the interview process will be contacted.