GMP Expert Consultants (closed)
Contract Position-24 months
Send resumes to :firstname.lastname@example.org
Travel: May require up to 10% travel
Leadership Responsibilities: The person will lead cross-functional team at the site, but no direct line management responsibilities
This contract is for approximately a 24-36 month period.
Provide guidance to the 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 Company Quality Standards, Enterprise Quality Standards and GMP’s
• Assure that the SOP’s and associated revised processes comprehensively address findings and
• 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
• • 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.
Most important skills and competencies for the position:
1. 10 years of relevant experience with increasing responsibility in the pharmaceutical or medical device industry
2. Experience in a Consent Decree preferred or FDA remediation experience
3. Blackbelt or ASQ certification. Six Sigma experience
4. Change controls experience is a must
5. Bachelor's Degree in Physical Sciences, Engineering, or a related discipline