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Computer Systems Validation Expert
2 months ago
**Computer Systems Validation Specialist**
The Computer Systems Validation Specialist plays a crucial role in ensuring the integrity and compliance of Pharmascience's computer systems. This position is responsible for guiding the validation process, performing impact and risk assessments, and providing guidance on validation strategies and approaches.
Key Responsibilities:
- Develop and implement validation plans, user requirements specifications, and protocols for computerized systems.
- Conduct impact and risk assessments for computerized systems, ensuring compliance with GAMP 5 and regulatory requirements.
- Provide guidance and recommendations on validation strategies, approaches, and testing to IT and project teams.
- Participate in system periodic reviews and system retirement, ensuring that all systems are properly validated and compliant.
- Ensure that IT change controls are assessed for impact, resolution is documented, tested, and approved to maintain the systems' validated state.
- Develop and deliver training on IT computer system validation procedures and FDA CFR 21 Part 11 to project teams.
- Participate in internal and external audits to ensure IT compliance with regulatory expectations, PMS internal policies, and procedures.
- Develop and maintain IT SOPs and training materials, ensuring that they are up-to-date and compliant with current GMP, quality, and compliance policies.
Requirements:
- Knowledge of Health Canada, GAMP 5, CFR 21 Part 11, and current Good Manufacturing Practices.
- Ability to execute validation strategies on activities surrounding the implementation of IT computerized systems.
- Ability to analyze requirements, assess risk, and determine the degree of compliance evidence necessary to satisfy compliance requirements.
- Good planning, prioritization, analysis, and project management skills.
- Good judgment in degree of compliance and risk.
- Bachelor's degree.
- Experience in a GxP environment (preferably in the pharmaceutical industry) and knowledge of related rules and regulations.
