IT VALIDATION TEAM LEAD (Contractor)

Budget N/A
Bids 5
Average Bid €43

A pharma company in the Amsterdam region is looking for a

IT VALIDATION TEAM LEAD (Contractor)
JOB SUMMARY:
The IT Validation Team Lead provides leadership for assigned projects and coordinates IT technical & validation project team resources and business resources in all aspects of IT project validation – planning, documentation development, test execution, and deviation identification and resolution for a pharmaceutical company global IT project portfolio.
WORK PERFORMED:
Team Leadership
• Deliver Validation Specialist and Validation Test Execution training as needed.
• Act as mentor to IT Validation Specialists.
IT Projects
• Lead teams composed of IT and business professionals in computer system validation activities.
• Leadership role in analysis of current business processes and translation/documentation of these into Functional & System Requirements.
• Author Validation Plan, Design Specification, IQ, OQ & PQ Protocols, Traceability Matrix and Validation Summary Reports for assigned projects.
• Manage authoring of High Level and Detailed Risk Assessments.
• Manage authoring, dry running, & review & approval of IQ, OQ and PQ test scripts.
• Manage preparation of all validation deliverables for presentation to QA for approval.
• Write up and manage resolution and final disposition of all Deviations identified during test execution.
REQUIRED SKILLS & KNOWLEDGE:
• Adept at coordinating competing priorities and projects. Broad experience in IT project validation and proven ability to lead validation activities of complex IT projects. This should include: understanding the business; determining business & system requirements; project planning; cost estimation, assigning validation project responsibilities; negotiating project deliverables
• Outstanding communication skills, both verbal and written. Ability to engage, interact, and negotiate effectively with project team members, both IT and business.
• Strong interpersonal, leadership and mentoring skills. Thorough understanding of risk management and mitigation approaches for complex organization and project issues.
• Results-oriented, pragmatic approach to problem solving. Ability to act as advocate for consensus on complex issues.
• Thorough understanding of how to work effectively within regulated pharmaceutical environment. Familiarity with U.S. FDA GxP, and U.S. FDA 21CFR Part 11, ISO 9001 systems validation. Experience in planning and execution of U.S. FDA-related Computer Systems Validation methodologies and project management implications.
• Thorough, applied understanding of SDLC and Project Methodologies.
• Experience in participating in large-scale business application deployment (e.g., SAP, Siebel, Cognos) and/or enterprise solutions for pharmaceutical, vaccines, or medical device manufacturing, research & development.( SAS applications)
• Occasional domestic and international travel may be required
DESIRED BACKGROUND & EXPERIENCE
• Understanding of client/server and web-based systems architecture concepts and network communications.
• Technical familiarity with Windows, Oracle, SQL, and Citrix technologies.
• Experience developing, implementing and supporting information systems in the pharmaceutical or biotechnology industries.
• Experience with systems integration and custom development projects
• Familiarity with network servers, PC clients, and telecommunications technologies
DESIRED EDUCATION & TRAINING
• Minimum requirement is a Bachelors degree in Computer Science or a related discipline.
• 5-8 years experience with information systems design, development, implementation and support, the last 3 of which involve computerized systems validation, preferably in the Pharmaceutical industry.
• A history of on-going professional training in topics such as project management, software engineering, validation, and client/server and web architectures.
• Proficient in use of all Microsoft Office solutions.

Post a Project Like This

Looking to make some money?

  • Set your budget and the time frame
  • Outline your proposal
  • Get paid for your work

Bids on this Project

  • Udayarajan Profile Picture

    Udayarajan

    Chennai,  India

    Name : Udayarajan G Experience : 14 yrs in QA/Testing 4 Years as Freelance Software Tester. 10 Years worked in Companies as Software Tester. Projects done as Freelance Software Tester. =============== a. COMCAST b. GENIUS c. globaleyeglasses d. dmsxgate e. supportmyprogram f. b-street g.www.kmb360 h.Testing of GLOBALEYEGLASSES.COM i. Testing of dms.xgate.com.hk j.Testing of supportmyprogram.com k.Testing of b-street.com Projects done while working in Companies ============================= KODIAK NETWORKS Customer: BELL CANADA. PROJECT: PushToTalk Over Cellular(POC): AVAYA Networks. COGNIZANT TECHNOLOGIES SOLUTIONS.(1 Year Feb 2007 to Feb 2008) Comcast Testing WIPRO TECHNOLOGIES. (6 Years and 3 Months)(Oct 2000 to Dec 2006) NORTEL DMS 100 SWITCH (WIPRO TECHNOLOGIES ): NORTEL OPTICAL NETWORKS (WIPRO TECHNOLOGIES). NORTEL MERIDIAN SWITCH(WIPRO TECHNOLOGIES). MOTOROLA LIBERTY EMS project (WIPRO TECHNOLOGIES). FUJITSU NETWORK CORPORATION Flashwave 7500 (WIPRO TECHNOLOGIES).

    Web Security, iPhone, Testing / QA, and SQL

  • getveltrod Profile Picture

    getveltrod

    Chennai,  India

    Veltrod Technologies is a global software consulting company specialized in providing Mobile applications, Social media frameworks and eCommerce solutions. Leveraging best-in-class people, processes, and technologies, Veltrod provides high-quality software development and BPO services to independent software vendors and enterprises. We are specialized in developing and testing Mobile applications, Search Engine optimizations, Social Network framework development, Website design and Development.

    JSP, Javascript, Ruby on Rails, and AJAX

  • autotesting2013 Profile Picture

    autotesting2013

    Bangalore,  India

    Testing Expert and ISQTB (Advanced) having 10 years of experience in Quality Assurance have competency in the Software Development Life Cycle (SDLC) and Test related standards such as IEEE829, IEE12207. ----------------------------------- Why In Freelancer: ----------------------------------- New member in Freelancer . Gained experience in 10 years from various leading software firms ; most of US companies; can bring in freelance work. Now working as Freelancer / Consultant / Corporate Trainer. ---------------------------------------------------- Domain Experience: ---------------------------------------------------- Healthcare Wealth Management Financial Domain Education Social Networking Travel ERP PMS ---------------------------------------------------------------- Types of Testing: ---------------------------------------------------------------- Functional Testing Regression Testing Database Testing Scenario Base Testing Exploratory Testing Performance & Stress Testing Android based Mobile Testing (APPs Testing). -------------------------------------------------- Testing Tools: -------------------------------------------------- Quick Test Professional (QTP ) JMeter ------------------------------------------------------ Documents: ------------------------------------------------------ Test Plans Test Scripts Test Cases Traceability Matrices Test Matrices UAT Plans Test Summary Report Feasible Testing Report Bug Report - summary and detail. ----------------------------------------------------- Certified: ---------------------------------------------------- ISQTB PMP NSE CCNA MCP ------------------------------------- Other Areas : ------------------------------------- CMMI - Good Understanding of CMMI Standards.

    Testing / QA, Software Testing, Test Automation, and Website Testing

  • guddu7 Profile Picture

    guddu7

    Bangalore,  India

    Leadership and management experience in excess of 13 years with an outstanding track record of coordinating, leading and managing the QA effort of complex IT projects, Software Testing, Software Quality Assurance, Project Management

    Java, XML, Linux, and Web Security

  • GandalfTheGrey Profile Picture

    GandalfTheGrey

    Katowice,  Poland

    IT Wizard. System and network administrator. Systems architect. Data recovery and forensic specialist. Security and performance optimizations. Distributed and parallel processing. Specialties: Security, Administration, Data Recovery and Forensic, Developer Environments, Virtual Environments, Heterogenous Systems, High Availability Servers ( web, ftp, e-mail ), Hosting Services, Debian GNU/Linux

    System Admin, Linux, Web Security, and Verilog / VHDL