About Me
Experienced professional (15 + years) with GxP validation such as 21 CFR Part 11, GAMP5 framework, Computerized System Validation (CSV) and practical line management experience in CRO/Pharma industry and experienced in Quality Assurance.
Identifying and implementing improvements of the IT system life cycle and validation processes to ensure Risk-based validation of GxP systems is in place
Responsible and coordinating validation activities in compliance with corporate policy, regulatory expectations, IT QMS, QA team
Audits preparation, representation, follow up activities
Collaboration, communication, collecting information on new changes in the GxP systems
Supporting, writing, reviewing and approving qualification, validation packages, like Change Request/Report, Validation plan/report, IT Risk Assessment, User Requirement, Functional Specifications, execution of various levels of validation protocols (OQ/PQ) for implementation of new FDA-regulated clinical trial management systems (CTMS), changes to existing EDC, etc.
Advise and providing trainings for team members about best practices for validation deliverables
Certified in: QMS internal auditor (ISO 9001:2015 & ISO 19011:2018), Scrum Master, ISTQB Test Manager, ISTQB Tester
Good understanding of ICH E6, ICH E3, ICH E8, ICH E9 and clinical research processes.
Extended documented experience with implementing and validating IT systems, as well as supporting and maintaining existing clinical and non clinical IT systems keeping them in a validated state
Advanced IT Test management background with professional experience in test methodologies, test processes, developing test schedules, implementing best practices with combined business analysis experience (requirements elicitation, documentation, validation, negotiation).
Demonstrating through previous experience by managing multiple projects -built test processes on for different projects from scratch including interview, hiring, performance review, career development.
Designing, review, implementing test strategies, test plans, functional, system, regression test cases, E2E tests, UAT organizing with end-users, report on test activities.
Experience working with cross-functional global teams (EU, USA, Asia) with product development, stakeholders, support roles to deliver quality product on schedule.
Able to interact professionally with a group of stakeholders, including senior executives, managers on all levels
Excellent analytical skills, written, verbal communication skills in English
Hire Remote Developers For Your Project
iT-Outstaffing.com is a reliable Staffing Vendor that provides
Remote
Developers
for your project within 24h on request
Skills description
If HTML is a basis of frontend programming, then the SQL is a key to the deep database programming and managing of almost every existing DBMS. Using this language, you can manage different data, filter and analyze information even in very large volumes.
In general, SQL first appeared in 1974, but it is still widely used by programmers who work with different databases platforms such as MySQL, because of its versatility and uniqueness. Did you know that a well-known Microsoft Access application is also based on the SQL? Yes, SQL is much closer than it seems. It’s everywhere!
Typically, experienced SQL developers are working with multiple platforms and databases systems. It is an incredibly big advantage! You can hire a highly qualified SQL database developer and get an expert advice from him or simply involve him in your project as a BackEnd SQL Freelancer. During one week you can test your candidate and if he will not satisfy you, we will replace him for another one without any difficulties!
Everyone who is expecting to get a professionally created software should take the services of professional QA Specialists. QA is a process of testing, inspection and resuming the requirements which are needed for the final end-product improvement.
Once your product is ready, or nearly ready, it should be quickly transferred to the professional QA freelance engineers for the QA-audit. Highly-qualified QA Freelancers will carry out all the required operations in order to identify shortcomings, errors or inconsistencies with your own terms of reference. This data will be sended to the developers, so they will improve all the problematic gaps and you will get a perfectly working software!
Most Full Stack QA Specialists you see on AOG have experience in large comprehensive projects for corporate clients based in the USA and even worldwide! Younger professionals were involved in local projects of medium complexity, so you can be strongly confident in the professionalism of your potential QA Ninjas!
