Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Job Description:
Computerized Systems Validation (CSV) position involves ensuring that GxP-regulated computer systems and software comply with current Good Manufacturing Practices (cGMP) regulations, international guidelines (like 21 CFR Part 11 and Annex 11), and company standards by validating their functionality throughout their lifecycle. Key responsibilities include developing and reviewing validation documentation (protocols, reports), performing risk and impact assessments, coordinating testing (UAT, SIT), managing change controls, and supporting audits to maintain the validated status of systems like ERP, MES, and LIMS.
Responsibilities:
- Documentation & Planning: Author, review, and approve CSV lifecycle documents, including validation plans, user requirements specifications (URS), risk assessments, protocols, and reports.
- Validation Execution: Coordinate and execute testing activities, such as User Acceptance Testing (UAT), System Integration Testing (SIT), and Installation, Operational, and Performance Qualifications (IQ, OQ, PQ).
- Regulatory Compliance: Ensure all computer systems comply with cGMP, 21 CFR Part 11, Annex 11, and other global regulatory requirements.
- System Lifecycle Management: Oversee the entire CSV lifecycle, from design and development to testing and ongoing maintenance of the validated status of systems.
- Change Control: Manage change controls, deviations, and non-conformances related to CSV to ensure continuous compliance.
- Cross-Functional Collaboration: Quality Assurance (QA), and automation teams, as well as stakeholders and vendors, to achieve project goals.
- Audits & Inspections: Support internal and external audits, including FDA inspections, by providing documentation and expertise on CSV activities.
- Data Integrity: Perform data integrity assessments for computer and automation systems to ensure data is accurate and reliable.
Requirements:
- A bachelor's degree in a technical, scientific, or related field, such as Engineering, Biology, or Chemistry, is often required or preferred.
- Master's degrees in related fields like Information Management, Information Technology, or Computer Science are sometimes preferred.
- Experience: Significant experience (often 9+ years) in Computerized System Validation (CSV) within the pharmaceutical or medical device industry.
- Knowledge: Thorough understanding of cGMP regulations, the software development lifecycle (SDLC), and CSV principles, especially 21 CFR Part.
- Software/System Experience: Familiarity with common GxP systems like ERP, MES, LIMS, and specific automation platforms such as DeltaV.
- Technical Skills: Strong documentation skills, experience with validation management software (e.g., Kneat), and an understanding of data integrity and cybersecurity principles.
- Soft Skills: Excellent communication, strong leadership, and the ability to collaborate effectively in cross-functional, global teams.