We are working with a dynamic andinnovative small to medium-sized Biotech looking for a QA Manager(GCP) to join their team. Their passionate team of scientists,clinicians, and professionals are committed to translating scientificdiscoveries into life-changing therapies for patients worldwide.
Key Responsibilities:
* Developand uphold GCP/ICH compliant processes to oversee the quality ofclinical trials.
* Support internal audits, CAPA, and qualitymanagement reviews.
* Collaborate with the Head of QA duringregulatory agency and client audits.
* Identifynon-conformances, offer recommendations, and drive qualityimprovements.
* Conduct vendor audits and foster continuousimprovement in service delivery.
* Facilitate training for ourclinical staff and manage our eQMS system effectively.
* Keepabreast of quality legislation and compliance issues, ensuringadherence to standards.
Required Skills &Qualifications:
* Bachelor's degree in Life Science orrelated field.
* Minimum 3 years of CQA experience in aregulated industry.
* Proficiency in ICH/FDA GCP guidelineswith practical knowledge.
* Familiarity with risk-based qualitysystems consistent with ICH E-6.
* Experience in FDA/EMAinspections and customer audits.
* Strong communication,attention to detail, and time management skills.
* Demonstratedwork ethic and commitment to quality.
If youare looking for an opportunity that challenges you whilst supportingyou in your career.... apply or drop me a call
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