Job description
Mission Description
We are seeking a highly experienced Senior CSV Validation Specialist with a robust background in IT validation, specifically within the pharmaceutical or healthcare industry. The ideal candidate will have prior experience working with organizations and possess a deep understanding of the Software Development Life Cycle (SDLC) framework, as well as strict adherence to industry procedures such as SOP-1705.
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Key Responsibilities
* Validation Planning: Develop and execute comprehensive validation strategies for Computer System Validation (CSV) projects, ensuring full compliance with industry standards and company policies.
* Documentation: Create and maintain detailed validation documentation, including validation plans, protocols, and reports in accordance with SOP-1705 and other relevant SOPs.
* Risk Assessment: Conduct risk assessments to identify potential validation issues and develop effective mitigation strategies.
* Testing: Lead and participate in CSV testing activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
* Collaboration: Work closely with cross-functional teams, including IT, Quality Assurance, and Regulatory Affairs, to ensure validation efforts meet project timelines and specifications.
* Compliance: Ensure strict adherence to regulatory requirements (e.g., FDA, ISO) and internal compliance standards throughout the validation lifecycle.
* Training: Provide guidance and training to team members on CSV best practices and procedural compliance.
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Profile Requirements
* Experience: 7 to 10 years of experience in CSV validation, preferably in a regulated environment.
* Industry Knowledge: Prior experience working within the healthcare or pharmaceutical sectors.
* SDLC Understanding: Comprehensive knowledge of the Software Development Life Cycle (SDLC) and its application within validation processes.
* Documentation Skills: Proven ability to create detailed, compliant documentation (SOPs, validation protocols, reports).
* Analytical Skills: Strong analytical and problem-solving skills to identify issues and implement corrective actions.
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Preferred Qualifications
* Bachelor’s degree in a related field (e.g., Computer Science, Information Technology, Engineering).
* Familiarity with industry standards and regulations relevant to CSV (e.g., GxP, 21 CFR Part 11).
* Experience with validation tools and methodologies.
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What We Offer:
* Competitive compensation package.
* Opportunity to work on high-impact projects within a leading organization.
* Collaborative and innovative work environment.
* Professional development and training opportunities.