For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
The GMP Auditor (specifically, ex-FDA) will be responsible for planning and conducting GMP audits (qualification, re-qualification, for-cause, and PAI readiness) on behalf of clients. Serve as a subject matter expert (SME) for GMP auditing in accordance with FDA regulations; specific experience in the following areas: Mock PAI, Medical Devices and Analytical QC Lab.Requirements• B.S./B.A. in a scientific discipline; a graduate degree in a scientific discipline is preferred.• Quality orientation and high attention to detail.• Experience with creating GMP documentation, including protocols, reports, and SOPs.• Effective written and oral communication skills, with the ability to convey information and instructions accurately.• Minimum of 5 years of GMP auditing experience in a related industry• High-level understanding of GMP auditing services in the pharmaceutical, medical device, and biotech industries.#LI-EB3
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
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