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QA Validation Specialist

3 months ago

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Responsibilities :
  • Execute and/or approve deliverables for the Site Validation Plan enabling overall strategic implementation of remediation and qualification activities within the site's 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 site's Inspection Readiness program for regulatory inspections, Client baseline audits /audits.
  • ctively 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.
Requirements:
  • 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 HA's.
  • 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.
  • bility 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.