GMP Quality Compliance Expert Job in King Of Prussia 19406, Pennsylvania US
Tunnell Consulting, Inc. is a successful employee-owned company providing technical, organizational and operational consulting. Our highly-experienced consultants actively work to create a team-based approach to all client projects. We utilize this approach to create innovative, integrated and differentiated solutions that add real value to our clients' operations. We are currently seeking GMP Quality Compliance Experts for a long term consulting project for one of our Pharmaceutical clients located in Suburban Philadelphia:
GMP Quality Compliance Experts
Job Description:
Provide guidance to the Client’s Quality Services Excellence teams relative to GMP and GDP compliance and industry best practices in Manufacturing and Distribution in the following areas:
- SOP clarity and alignment of requirements in the client Enterprise Quality Standards and GMP’s
- Assure that the SOP’s and associated revised processes comprehensively address findings and Quality System element is remediated.
- Good Documentation Practices
- Investigations: clarity, completeness, root cause determination, corrective actions, preventative actions, timeliness
- Training: Ensure training content is defined and executed per role/
- Change Controls: Provided mentorship within the change control process.
- Ability to review complex data, and provide professional recommendations, where needed.
- Metrics design, review, trending and continuous improvement response
- Evaluate points for further evaluation from other QSE's, and incorporate, as needed.
- Provide guidance and assist in corrections required to produce a GMP compliant documentation of remediation work.
- Provide GMP/ Quality Assurance/ Quality Systems guidance in the development of effective and efficient Quality Systems.
- Establish training on Lessons Learned from identification of areas of GMP improvement opportunities.
· Leadership Responsibilities: The person will lead cross-functional team at the site, but no direct line management responsibilities.
Most important skills and competencies for the position:
- 10 years of relevant experience with increasing responsibility in the pharmaceutical or medical device industry
- Experience in FDA remediation experience
- Blackbelt or ASQ certification highly desirable. Six Sigma experience
- Change controls experience is a must
- Bachelor's Degree in Physical Sciences, Engineering, or a related discipline,
Please email Rosemary Menna, Human Resources Team, Tunnell Consulting for more information, rosemary.menna@tunnellconsulting.com .