Lead GxP Auditor/ SME
Contract W2
12 Months
No Travel Required
Remote
Depends on Experience
Techridge, Inc.
Fitment
Dice Job Match Score™
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Job Details
Skills
- GxP
- Auditor
- Medical device
- Pharma
- Regulatory
- Compliance
Summary
Required Skills:
- Bachelor's degree in a life science, engineering, or related technical field.
- 10+ years of experience in quality assurance, regulatory compliance, or auditing in the pharmaceutical, medical device, or combination product industries.
- Proven experience as a lead GxP auditor, including audit program development and execution.
- Deep working knowledge of combination product regulations and drug and device quality system requirements.
- Familiarity with global regulatory frameworks (FDA, EMA, MHRA, Health Canada, PMDA, MFDS, TGA, Medsafe).
- Demonstrated experience developing and delivering training to technical and cross-functional audiences.
- Strong presentation, facilitation, and stakeholder communication skills.
- Able to travel to client sites as required.
Preferred Skills:
- Advanced degree in a relevant discipline.
- Professional certification such as ASQ CQA, CQE, or RAC.
- Experience supporting inspection readiness and regulatory inspections.
- Consulting experience in client-facing, time-and-material engagements.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
- Dice Id: 10125172
- Position Id: 9108300
- Posted 9 hours ago
Company Info
About Techridge, Inc.
We believe we have the know-how to do it right the first time and we also understand that our client focus will always be on
-High Quality
-Cost Effectiveness
-Total Convenience
-Continuous Training
-Emphasis on Security
-Industry recognized SDLC
-Intelligent Communication
Technology and business knowledge go hand in hand in today s digital age, it very important to remember that technology will always remains a support mechanism for business. The greatest resource that makes any business successful is people, people who understand your business needs and technology. Techridge s hiring processes allows us to hire the right people based technical expertise on Attitude, Communication, Technical and Industry knowledge. Most of our employees have post graduate degrees.
At Techridge, we satisfy your need to keep up with lightning fast technology, manage constant system updates and control ongoing work by providing qualified IT professionals. People with the expertise to help you charge ahead of industry trends and the competition.
Careers
-High Quality
-Cost Effectiveness
-Total Convenience
-Continuous Training
-Emphasis on Security
-Industry recognized SDLC
-Intelligent Communication
Technology and business knowledge go hand in hand in today s digital age, it very important to remember that technology will always remains a support mechanism for business. The greatest resource that makes any business successful is people, people who understand your business needs and technology. Techridge s hiring processes allows us to hire the right people based technical expertise on Attitude, Communication, Technical and Industry knowledge. Most of our employees have post graduate degrees.
At Techridge, we satisfy your need to keep up with lightning fast technology, manage constant system updates and control ongoing work by providing qualified IT professionals. People with the expertise to help you charge ahead of industry trends and the competition.
Careers
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