QA Validation Specialist - Katalyst Healthcares & Life Sciences
Millburn, NJ 07039
About the Job
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.
- 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.
- 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.
- 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.
Source : Katalyst Healthcares & Life Sciences
