Quality Assurance Specialist

8 months ago


مصر, Egypt Ray-Cro Full time

Ensures that all quality Assurance
- related activities surrounding a clinical trial are compliant with all regulatory requirements and ICH-GCP standards.
- Establishing a document Control system and ensure compliance of SOPs with the local regulations & ICH-GCP.
- Ensure that proper on the job Training Schedule is set to every employee in RAY
- Responsible for Conducting internal and external audits to ensure compliance with company SOPs, GCP and local regulations.
- Conduct audits of clinical Study documents, including Investigator Brochures, Clinical Protocols, Clinical Study Reports, Case Report Forms and Informed Consent Form
- Member of the RAY excellence team, responsible for Implementation & follows UP of Excellence Project action plans.
- Report Significant Clinical Quality deficiencies to QA management and helps him to complete corrective action Tasks.
- Develop Quality Operations Process and Procedures for GCP QA in Compliance with applicable regulatory requirements.
- Provide GCP QA Guidance to clinical Operations based on analysis and interpretation of Updates to CP regulations to assure best practices
- Support preparation, Coordination and management of regulatory inspections, including Sponsor/ monitor inspections and Clinical Investigator Inspection.
- Develop and ensure timely execution of the GCP Audit Plan. Conduct GCP compliance Audit of Investigator Sites, Facilities, and Vendors in accordance with Audit Plans
- Support the administration of the Company’s training Program. Conduct GCP training, clinical Team members, investigators and clinical site staff as needed.

**Qualification**:

- Bachelor's degree in a related field required (Physician / Dentist/ Pharmacist)
- Communication in English.
- Aware of Good Documentation Practice is a must



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