Senior Csv Analyst

Minimum 10+ years of experience in Computer system validation with solid understanding of Good Manufacturing Practice (GMP) regulations
- Solid understanding of the variety of these types of computerized systems to qualify systems which impact cGMP operations using a risk based methodology
- Assist with the development of system requirements and specifications to ensure requirements that are testable and 21 CFR Part 11 requirements are met
- Evaluate proposed changes to validated computer systems and recommend level of validation activities required
- Develop CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan
- Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans
- Execution of validation plans and validation documents
- Work with overall project manager to include validation activities in implementation timelines
- Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents.
- Work closely with Validation Manager and QA Compliance to ensure appropriate validation of cGMP computer systems
- Able to work collaboratively and in a client focused environment. Have the highest standards for quality, accuracy, and professionalism
- Be highly motivated, organized, and able to manage priorities. Have excellent communication, presentation, and interpersonal skills

Art der Stelle: Vollzeit