IT Validation Expert

2 months ago

Montreal, Quebec, Canada Pharmascience Full time

About Pharmascience

Pharmascience is a leading generic drug company with a global presence. We pride ourselves on our commitment to quality and compliance, and we're looking for a skilled professional to join our team.

Job Summary

We're seeking a highly experienced Computer Systems Validation Specialist to guide the validation of our computer systems. This is a critical role that requires a deep understanding of GxP regulations and industry best practices.

Key Responsibilities

  • Develop and implement validation strategies for computerized systems, ensuring compliance with Health Canada, US FDA CFR Part 11, and EU Annex 11 regulations.
  • Conduct impact and risk assessments for computerized systems, using GAMP 5 guidelines.
  • Prepare and coordinate the development of validation documentation, including validation plans, URS, specifications, IQ/OQ/PQ/data migration/cut-over protocols, trace matrix, and validation summary reports.
  • Provide guidance and recommendations on validation strategies, approaches, and testing to IT and project teams.
  • Participate in system periodic reviews and system retirement.
  • Ensure new and existing implemented IT computerized GxP systems are validated and compliant with all applicable regulations.
  • Ensure infrastructure components are qualified.
  • Ensure IT change controls are assessed for impact, resolution is documented, tested, and approved to maintain the systems validated state.
  • Provide training on IT computer system validation procedures and FDA CFR 21 Part 11 to project teams.
  • Participate in IT supplier evaluation and qualification of vendors.
  • Participate in internal and external audits, ensuring IT is compliant with regulatory expectations, PMS internal policies, and procedures.
  • Develop IT SOPs and training material.
  • Recommend improvements to validation and qualification processes.
  • Maintain knowledge of current GMP, quality, and compliance policies and industry good practices for quality systems into the IT department.

Requirements

  • Knowledgeable of Health Canada, GAMP 5, CFR 21 Part 11, and current Good Manufacturing Practices.
  • Able to execute validation strategy on the activities surrounding the implementation of IT computerized systems.
  • Able to analyze requirements, assess risk, and determine the degree of compliance evidence necessary to satisfy compliance requirements.
  • Good planning, prioritization, analysis aptitudes, and able to manage simultaneous project rollouts.
  • Good communication skills.
  • Good judgment in degree of compliance and risk.
  • Good organization, problem-solving, and decision-making skills.

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