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About
Find out exactly what skills, experience, and qualifications you will need to succeed in this role before applying below.
- Minimum 8+ years of experience in Computer system validation with solid understanding of Good Manufacturing Practice (GMP) regulations.
- Candidates with experience on Siemens S7 PLC controllers, WinCC Unified HMI Scada and commissioning/qualification would be ideal.
- 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.
- 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. xcfaprz Have excellent communication, presentation, and interpersonal skills.
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Languages
- English
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