• Validation Analyst

    Job Locations UK-LND-Hammersmith
    Job ID
    2019-3313
    Category
    Quality Assurance
    Position Type
    Permanent Employee - Full-Time
  • Role Overview

    Validation Analyst - Hammersmith, London

     

    Bracket and CRF Health have combined to bring our clients a comprehensive suite of proven patient-centric clinical trial technology solutions, supported by deep therapeutic area expertise, to help you bring life-changing therapies to our families and communities around the world.

     

    Visit www.crfhealth.com and www.bracketglobal.com to view more information about these two, great organisations now merged in to one company. Our new web pages and corporate identity to go live very soon.

     

     

    The Validation Analyst is responsible for understanding software validation in a government regulated environment with special attention to the Software Development Lifecycle (SDLC) validation processes which meet regulatory requirements.

     

    The Validation Analyst ensures that all study work is conducted to CRF-Bracket’s procedures and processes and supports the CRF-Bracket Validation Methodologies. The goal of the Validation Analyst is to foster and promote quality throughout the SDLC/PLC.

     

    The position requires a high level of integrity as this person is working on a client’s project and preparing documents that may be submitted to regulatory agencies (FDA, EMEA etc.) as needed, and actions impact the quality and reliability of the client's’ product.

     

    Key Accountabilities/Decision Making & Influence

    Essential Duties and Responsibilities:

     

    • Work with internal staff in implementation of improved capabilities in the areas of documentation
    • Assist in performing analysis of current validation situations, review internal controls.
    • Propose validation improvement suggestions.
    • Compose and document validation strategies; Validation Plans, Validation Summary Reports, and other validation documents as needed.
    • Collaborates with other departments to ensure validation activities are executed in a compliant fashion
    • Interface with Client Services, Technical Delivery, QA, and Support Staff to ensure compliance with the SDLC/PLC.
    • Review documentation for accuracy and completeness, tracking and driving completion of Validation milestones per the project schedule.
    • Creation of detailed Validation execution schedules.
    • Interface with Project controls.
    • Attend project meetings.
    • Providing quality oversight, cross-checks and approvals

    Knowledge, Skills & Attributes

    Skills & Competencies

    Education

    • Bachelor’s degree or commensurate experience

     

    Experience

    • At least 1 year of work experience
    • Supporting multiple projects/processes in a fast-paced work environment.

     

    Competencies & Personal Attributes

    • High degree of self-motivation and attention to detail.
    • Superior verbal/written communication and interpersonal skills including the ability to deliver information effectively and facilitate team processes in person and via telephone or e-mail.
    • Ability to work collaboratively and take direction from multiple inputs.
    • Ability to manage and meet multiple deadlines and respond to multiple requests for support.
    • Proficient computer skills including Word, Excel, Outlook and PowerPoint. Familiarity with Visio preferred.
    • Ability to quickly learn and apply new skills, procedures and approaches.
    • Demonstrated ability to meet very short deadlines & multi-task in an extremely fast-paced work environment with little direct supervision.
    • Proven ability to work in a team-oriented environment, providing back-up support to team members & establishing/maintaining effective work relationships with co-workers within and across functional areas.
    • Previously demonstrated proactive and positive approach to tasks and projects overall, as well as to the types of scheduling and process changes that are inherent in a fast-paced business.

     

     

     

    CRF Bracket was formed in 2018 by the merger of CRF Health and Bracket to provide life science companies with patient-centric technology solutions that advance clinical research and transform the patient experience. Our solutions are trusted by pharmaceutical companies of all sizes, including all of the top 20 pharmas, as well as CROs, biotechs, and academic institutions on over 4,000 global clinical trials. For nearly 20 years, we have been committed to helping life science companies bring life-changing therapies to patients and communities around the world. The culture our founders instilled continues to drive our values today as we are innovative, results-driven, and deeply committed to our customers. We believe each and every person in our company plays a part in our success—our employees are proud, passionate, and own their contributions, both individually and in collaboration with an inspiring team of colleagues.

    • Our US offices are in Plymouth Meeting, PA; Wayne, PA; Trevose, PA; Boston, MA; Arlington, VA; San Francisco, CA; and San Diego, CA
    • Our UK offices are in Hammersmith, London; Reading; and Sandwich, Kent
    • Our Finland office is in Helsinki
    • Our Romania office is in Iasi
    • Our Japan office is in Tokyo
    • Our Czech Republic office is in Prague
    • Our India office is Hyderabad

     

    More information on our organisation to be found at: www.crfhealth.com and www.bracket.com and we will be announcing the arrival or our new combined website very soon.

     

     

     

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