Planning, preparation, conduct, reporting and follow up of various types of GMP audits according to expected quality and timelines
Executing audits based on a comprehensive understanding of all regulatory requirements and Good Manufacturing Practice (GMP)
Performing GMP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry.
Experience in conducting and leading internal and external GMP audits for a variety of stakeholders
Experience in conducting a range of service provider audits would be an advantage (e.g., API manufacturers, CMOs)
Experience in coordinating and managing inspection preparation activities for GMP process inspections both at the sponsor and investigator site.
Experience and full understanding of current applicable regulatory standards.
Expert knowledge of national and international GMP legislation and guidelines
Proficient in managing projects and ensuring deliverables are provided in a timely manner
Ability to identify issues and offer solutions in a pragmatic way
BS in Life Science preferred
Up to 40% travel and ability to conduct remote audits
Why ADAMAS?
When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.
Quality: we hold ourselves to the standard patients deserve.
Integrity and trust: we do the right thing, especially when it is hard.
Drive and passion: we care about the outcome, because someone is waiting on it.
Agility and responsiveness: we move quickly, because patients cannot wait.
Belonging: everyone is welcome, and every voice counts.
Collaborative partnerships: we go further by going together.
We look forward to welcoming your application.