GCP Compliance Specialist
hace 4 semanas
**Job Summary**
At Adamas Consulting, we are seeking a highly skilled GCP Compliance Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring the highest standards of compliance with Good Clinical Practice (GCP) regulations.
**Key Responsibilities:**
- Plan, prepare, conduct, report, and follow up on various types of GCP audits according to expected quality and timelines.
- Execute audits based on a comprehensive understanding of all regulatory requirements and Good Clinical Practice (GCP).
- Perform GCP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry.
- Assist with business development activities.
**Requirements:**
- BSc in Life Science preferred.
- Experience in conducting and leading internal and external GCP audits for a variety of stakeholders.
- Experience in conducting a range of service provider audits (e.g., full-service CRO, biostatistics, data management, phase I).
- Experience in conducting GCP systems audits.
- Experience in coordinating and managing inspection preparation activities for GCP process inspections both at the sponsor and investigator site.
- Experience in conducting GCP mock inspections to Competent Authority standard considered a significant advantage.
- Expert knowledge of national and international GCP legislation and guidelines.
- Up to 40% travel and ability to conduct remote audits.
**Why Adamas Consulting?**
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders, and ages can contribute and grow.
We offer:
- Training and career development opportunities internally.
- Strong emphasis on personal and professional growth.
- Friendly, supportive working environment.
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