Computer System Validation

5 months ago

Oakville, Canada Architecture in Motion Inc. Full time

**Job Overview**:
**Key Responsibilities**:

- **Develop and Execute CSV Plans**:

- Create and maintain comprehensive validation plans, protocols, and reports for computerized systems.
- Ensure validation activities are conducted according to GAMP 5 guidelines and meet all regulatory requirements (FDA, EMA, TGA, etc.).
- **System Assessment**:

- Perform GxP impact assessments for new and existing computer systems.
- Conduct risk assessments to identify potential issues affecting product quality, patient safety, and data integrity.
- **Documentation**:

- Prepare and review User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), and other related documents.
- Maintain detailed and accurate validation documentation, including traceability matrices, test scripts, and validation reports.
- **Testing and Qualification**:

- Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
- Conduct system testing, including unit, integration, and user acceptance testing, to ensure systems meet specified requirements.
- **Compliance and Audit Support**:

- Ensure systems comply with 21 CFR Part 11 and other relevant regulations.
- Support internal and external audits by providing validation documentation and responding to auditor inquiries.
- **Training and Support**:

- Provide training to system users on validated systems and procedures.
- Collaborate with IT, Quality, and other departments to address validation-related issues and improvements.
- **Continuous Improvement**:

- Stay current with industry trends, regulatory changes, and advancements in CSV methodologies.
- Identify and implement process improvements to enhance the efficiency and effectiveness of the CSV program.

**Qualifications**:

- **Education**:

- Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field.
- **Experience**:

- Minimum of 5 years of experience in computer system validation within the pharmaceutical industry.
- Extensive knowledge of GAMP 5 guidelines and regulatory requirements (e.g., FDA, EMA, TGA).
- Proven experience with validating a variety of computerized systems, including ERP, LIMS, MES, and QMS.
- **Skills**:

- Strong analytical and problem-solving skills.
- Excellent documentation and technical writing abilities.
- Effective communication and interpersonal skills.
- Ability to work independently and as part of a cross-functional team.
- **Certifications**:

- Relevant certifications such as Certified Quality Auditor (CQA) or GAMP 5 certification are a plus.

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