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QA Validation Specialist

Company: Katalyst Healthcares & Life Sciences
Location: Millburn
Posted on: May 28, 2023

Job Description:

Roles & Responsibilities:

  • Execute and/or approve deliverables for the Site Validation Plan enabling overall strategic implementation of remediation and qualification activities within the sites commitments.
  • Work in close collaboration with site-based SMEs to ensure the implementation of robust, high-quality deliverables, with clear alignment between inspection SMEs and site leadership.
  • Review and approve actions related to facility, computerized systems, laboratory or products. Ensure proper assessment with respect to Qualification and Validation is conducted. Performs QA oversight for Validation and Qualifications activities for Manufacturing, QC and other GMP support areas.
  • Review and approval of deviations / non-conformances and lead the strategic discussion for investigations with respect to operations or validation related matters.
  • Support the sites Inspection Readiness program for regulatory inspections, Client baseline audits /audits.
  • Actively drive high quality deliverables at the site by promoting a high standard of Quality Culture. Helps build and drive a culture of compliance throughout the organization.
  • Inspire change management initiatives and embed collaboration forums across the sites and as required with stakeholders. Control project scope to limit schedule changes and to capture changes of scope that may arise.

    Education & Experience:

    • B.S. degree in Science, Engineering or related field with 5 years relevant experience or MSc with 3 years of relevant experience.
    • 5 years of experience in Pharmaceutical Manufacturing preferred, at least 3 years combined of relevant experience in quality-based roles including experience in GMP and/or laboratory operations required.
    • Proven track record and practical experience in establishing and maintaining quality systems, in facility changes and validation as well as successfully managing authority inspections from major HAs.
    • In-depth knowledge of cGMP's, especially FDA regulations 21 CFR Parts 11 with preferred understanding of regulations for computerized systems
    • Strong understanding and operating awareness of working in a pharmaceutical company. Experience in regulatory agency and partner/collaborator inspections.
    • Good understanding of local/National Health Authorities regulations and Client standards.
    • Demonstrated ability to problem solve and mediate complex issues. Project management capabilities preferred.
    • Strong communication, leadership and team working skills.
    • Effective in prioritizing, shows the appropriate sense of urgency around prioritized tasks. Flexibility and ability to prioritize and manage multiple tasks simultaneously.
    • Creative thinker in ways in which we can ensure better compliance and systems (A risk-based approach to Quality and Compliance).
    • Demonstrated excellence in written and verbal communication. Ability to effectively communicate at all levels in the organization oral and written.
    • Demonstrated ability to work cross-functionally Highly motivated, driven and have a passion to be part of a fast-paced team.

Keywords: Katalyst Healthcares & Life Sciences, New York , QA Validation Specialist, Other , Millburn, New York

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