IT Validation Expert
7 days ago
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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