QMS SOP Writing - Remote

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. As the world’s largest RCO (Research Consulting Organization), 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.

Responsibilities

• Implement policies, procedures and forms in preparation of corporate audit and internal QP inspection.
• Finalize documents that are in various stages of development prior to the inspection.
• Documents cover all systems, including manufacturing, lab, packaging, quality, etc.

Experience and Qualifications

• Experience in Radiopharma
• Knowledge of general quality and GMP systems.
• SOP writing skills
• Experience with QMS systems.

*2 to 3 month contract opportunity; fully remote working.