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.
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