Quality Assurance Specialist

Quality Assurance Specialist The ideal candidate will be responsible for conducting internal and external audits to verify compliance with Good Clinical Practice (GCP) guidelines, company standard operating procedures (SOPs), and other relevant regulations. A key aspect of this role is evaluating and maintaining the company's quality management system (QMS). This involves reviewing quality events, incidents, and complaints to identify root causes and recommend corrective and preventative actions (CAPAs). The successful candidate will also be responsible for preparing detailed reports that document findings, non-conformities, and recommendations for improvement. Additionally, they will need to stay up-to-date with all applicable regulations and guidelines from bodies like the FDA and ICH. This position requires a bachelor's degree in a relevant field or equivalent audit experience. The ideal candidate should possess working knowledge of US FDA Good Clinical Practices (GCP), Internal Conference of Harmonization (ICH), Electronic Records; Electronic Signatures (21 CFR part 11), EU Annex 11, GDPR, or GAMP 5. The selected candidate should have strong analytical and problem-solving abilities for identifying discrepancies, evaluating data, and drawing logical conclusions from audit findings. They must also possess a meticulous and detail-oriented approach to reviewing documents, data, and processes. Excellent written and verbal communication skills are essential for articulating audit findings and working collaboratively with diverse teams and stakeholders. A thorough understanding of GCP, ICH guidelines, and other relevant clinical trial regulations is necessary. Certifications from professional bodies can be advantageous.

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