QA - GCP Officer

Main Duties And Responsibilities

• Ensure that all clinical trial activities comply with relevant GCP regulations, guidelines, and standard

operating procedures (SOPs).

• Review clinical hial protocols to ensure they meet GCP standards and regulatory requirements.
• Ensure accurate and complete documentation of all clinical trial activities, including but not limited

to study protocols, informed consent forms, and trial master files.

• Review clinical trial reports, ensuring they meet regulatory and GCP requirements.
• Check and follow up on the following (studies close out, dispensing and clinical conduct procedures).
• Stay informed about developments in GCP regulations, guidelines, and best practices, and incorporate updates into company procedures and practices.
• Assure implementation and compliance with international standards and regulations regarding bioequivalence studies, Good Clinical Practice.
• Review all APIC studies on relevant GDP and GCP requirements.
• Ensure that the environment and instruments records are qualified for the conducted studies
• Ensure that the training and delegations for the participating employees are available and comply with study requirements.
• Participate in Internal audit on APIC Operations and facility when needed.
• Review and update the quality assurance procedure as appropriate when needed

Job Requirements

• B.Sc. in pharmacy.
• Minimum 0-2 years of experience.
• Good management skills and leadership abilities.
• Good communication skills.
• Good command of Arabic and English languages both spoken and written.
• Good computer skills including windows, Microsoft Offrce (Excel, Word, PowerPoint, etc.)