QA Validation Specialist
Company: Katalyst Healthcares & Life Sciences
Posted on: May 28, 2023
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
- 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
- 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
- In-depth knowledge of cGMP's, especially FDA regulations 21 CFR
Parts 11 with preferred understanding of regulations for
- Strong understanding and operating awareness of working in a
pharmaceutical company. Experience in regulatory agency and
- 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
- 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
- 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
Keywords: Katalyst Healthcares & Life Sciences, New York , QA Validation Specialist, Other , Millburn, New York
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