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CSV Validation Specialist
2 months ago
Katalyst Healthcares & Life Sciences is seeking a highly skilled CSV Validation Specialist to join our team.
Job Summary:The CSV Validation Specialist will be responsible for providing technical leadership and accountability for overall computer system validation efforts. This includes ensuring quality and compliance in accordance with established procedures and standards of the Quality Systems by applying critical thinking on CSV work.
Key Responsibilities:- Generate, review, and approve base-level documents such as Validation Plans, URS, FRS, DS, and SOPs in support of Computerized System Validation/Assurance activities.
- Develop, implement, and maintain computer system validation-related controlled documents to support the initiation, validation, operation, and maintenance of GxP systems.
- Assist with change controls, CAPAs, deviations, exceptions required as part of system validation efforts.
- Support system administrative & maintenance activities for Lab Systems.
- Perform gap analysis & necessary remediation efforts on current computer systems to ensure compliance with Part 11 and Annex 11.
- Collaborate/lead/participate in decision-making and make recommendations regarding the best options for validation of computer systems.
- Collaborate with Revance-approved vendor personnel in coordinating validation efforts including reviews/approvals of related validation deliverables.
- Reviews department-specific SOPs periodically and updates if/as needed to ensure that the procedures are always up to date based on the latest regulatory updates and industry best practices.
- Perform system assessments based on version upgrades/release updates on SaaS/Cloud-based GxP systems and ensure all the required verification and validation efforts are performed per the assessments conducted.
- Facilitate the computer system validation risk assessments i.e. System level, Requirement level risk assessments, & System and Data Audit Trail assessments, etc.
- Develop or assist with business process deliverables such as process flows, data flows, user/operating procedures, work instructions, and forms for GxP computerized systems.
- Perform Periodic System Reviews ensuring that the systems maintain their validated status.
- Support Regulatory inspections and internal and partner audits, and implements corrective actions as needed in CSV.
- Minimum of Six (6-8) years or more in the pharmaceutical industry with GMP experience.
- Understanding phases of Life Cycle Validation approach and practical working knowledge of computer system validation/computer software assurance requirements.
- Knowledge of validation of cGMP automation/computerized systems within an FDA regulated environment with a strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9, and Q10.
- Demonstrate ability to effectively manage multiple projects/priorities.
- Demonstrate excellent written and oral communication skills.
- Effective time management and interpersonal skills.
- Must work effectively within teams with rapidly changing priorities.
- Demonstrates analytical problem-solving skills.
