| Looking Onsite || Computer System Validation with Medical Device & Regulations || Puerto Rico, TX (Onsite) at Rico, Colorado, USA |
| Email: [email protected] |
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From: Gaurav, Quantum World IT [email protected] Reply to: [email protected] Greeting, I hope all is well with you For the following, Quantum World IT is seeking the best consultant profile. Please respond with your most recent resume if you are considering new opportunities. Looking Onsite || Computer System Validation with Medical Device & Regulations || Puerto Rico, TX (Onsite) Role Description: | Computer System Validation (CSV), Validation, IQ, OQ, PQ, FAT, SAT | Competencies: | EIS : Medical Device & Regulations | Essential Skills: | Validation & CSV Lead EngineerMinimum of 5 Yr exp leading the validation of a major capital automation projects.1. Validation and Compliance Knowledge GxP (Good Practice) Guidelines: Familiarity with GxP guidelines such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP). FDA 21 CFR Part 11: Understanding of the regulatory requirements related to electronic records and signatures. ISO Standards: Familiarity with ISO 9001, ISO 13485 (for medical devices), and ISO/IEC 27001 (for information security). Validation Lifecycle Management: Knowledge of the entire lifecycle from planning, execution, and reporting, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).2. Computer System Validation (CSV) Expertise CSV Methodologies: Strong understanding of CSV processes, including risk-based approach, qualification testing, validation protocols, and traceability matrix development. System Integration & Interface Testing: Skills in validating interfaces between different systems, including ensuring data integrity during integration. Software Testing: Experience with software test methodologies (e.g., functional, performance, stress testing). Documentation & Reporting: Creating and maintaining validation documentation such as protocols, reports, and deviations. Proficiency in technical writing is key.3. SCADA, SAP4. Nice to have: Work experience in the medical device industry | Desirable Skills: | Minimum of 5 Yr exp To have full technical oversite and lead the overall validation & qualification of the equipment and processes. To develop the overall validation and qualification plan\\strategy in compliance with onsite governing procedures and aligned with the engineering Technology department, delivering the overall project. Creation of quality validation process flow (e.g., V up to and including Regulatory submission). To promote and support an effort to have a common approach to documentation and strategies. To lead, Support, guide, and coordinate validation activities with the team members to ensure adequate resource assignment, task prioritization and progress monitoring according to schedule. Collaborate with the QA Team to ensure there is agreement to the overall strategy, resolve any issues that arise and to work through the tasks to complete the overall project. Lead / develop the vision attribute agreement analysis test criteria. E.g., Attribute Agreement Analysis, Linearity & Bias etc. Action plan developed for each of the key deliverables. FAT & SAT Protocol Report and Test Plan Report Completed. Lead the execution of IQ, OQ & PQ Testing. IQ | OQ | PQ Documentation Report Completed. Must have very good written and verbal communication skills. Customer support experience preferred. Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required. Employee must be able to effectively prioritize and manage multiple activities and responsibilities. Ability to function in a team environment and deliver on team objectives is required. Ability to make decisions and solve problems while exhibiting situational judgement. Bachelors Degree in Engineering, or a related technical field. | Country: | United States | Please enter the following information is needed for submission and Photo id Position Applied for | | Candidate Full Name [As per Passport] | | Contact Number Primary & Secondary | | Current Location | | Email | | Work Authorization | | Total years of Experience | | Had ever worked with TCS in Past (Required filed) | | Have you gotten covid Vaccination does | | LinkedIn ID | | Are you comfortable for on-site | | Rate | | Gauarv Kumar Phone: +1 8053915957 Email: [email protected] Quantum World Technologies Inc. 4281 Katella Ave, Suite #102 Los Alamitos CA 90720 USA Keywords: quality analyst information technology California Idaho Texas Looking Onsite || Computer System Validation with Medical Device & Regulations || Puerto Rico, TX (Onsite) [email protected] |
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| 08:56 PM 03-Feb-25 |