Hello All, Greetings of the day,
Hope you are doing well. I have an urgent requirement of "CSV LEAD" to locate "Remote" Please have a look and let me know if you are interested. Role:-CSV Lead Location:- Remote JD:- . Prepare timeline, tasks and due date for each validation activities. Collaborate with all stakeholders of different systems to ensure validation timelines are adhered. . Support Change Management, System Assessment and Security Assessment of the system . Evaluate proposed changes to validated computer systems and recommend level of validation activities required . Create/Review/update Validation documents like Validation Plan, System Description document, Requirement specifications, Design Specifications, Configuration specification, Requirement Traceability Matrix, . IQ and OQ protocols, Data Integrity Assessment, Administrative and Operations/Business SOP, Validation Summary Report . Work with testing team to develop testing strategy in accordance with client's policy and procedures . Review/Update Test Cases as per Testing procedure . Review Test Execution and Defect Management . Support User Acceptance Testing . Work closely with QA Compliance to ensure appropriate validation of GxP computer systems . Provide regulatory guidance on principles of CSV to the expanded team . Conduct or facilitate validation and Testing training . Ensure Quality & Compliance per Amgen SOPs and Guidelines . Highlight risk and propose mitigation plan Experience Requirements: . Minimum 5 years of experience of working as Validation Lead for GxP software development project. . Extensive knowledge on Validation methodologies, processes and regulations, which includes 21 CFR Part 11, Good Automated Manufacturing practice (GAMP 5), Computer Software Assurance (CSA) . Experience of working in GMP, GCP and GPvP systems . Proficiency in authoring and reviewing Validation documents including Standard Operating Procedures, ensuring Good Documentation Practices as per Life Sciences compliance. . Highly knowledgeable and capable in providing GxP solutions and guiding/mentoring all stakeholders . Experience of supporting System Assessment/Classification, Risk Assessment and Change Management activities in tools like TrakWise and Service Now. Well versed in ALM and JIRA. -- Thanks and Regards, https://ci3.googleusercontent.com/mail-sig/AIorK4y7PU8ViJeACdbC59sm6odYzop9g 4SDnGETJcTmTV1BkUs6tOrDe4lajBvlz1Zz7WVWV29yWms Prakash Tiwari Talent Acquisition Team - North America || Klaxontech, Inc. Sr. Technical Recruiter Email: - <mailto:[email protected]> [email protected] Hangouts:- <mailto:[email protected]> [email protected] Direct:- 201-442-8725 Text Now:- 862-901-2855 URL: <https://www.klaxontech.com/> https://www.klaxontech.com/ LinkedIn URL: <https://www.linkedin.com/in/prakash-tiwari-472604169/> https://www.linkedin.com/in/prakash-tiwari-472604169/ -- You received this message because you are subscribed to the Google Groups "Android Discuss" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To view this discussion on the web visit https://groups.google.com/d/msgid/android-discuss/00e201d8dd84%2417d49920%24477dcb60%24%40com.
