Quality Assurance Officer Job

Responsibilities

• Ensure compliance with relevant guidelines, Controlled Documents, and study protocols through the following actions:
• Conduct study-specific audits on identified critical phases.
• Perform audits on study schedules, study protocols (including amendments), and final study reports (including data, graphs, and tables).
• Conduct audits on system/facility and processes, directed audits, and evaluation of subcontractors and outsourced companies.
• Coordinate/ facilitate the hosting of sponsor audits and regulatory inspections at the Study Site.
• Operational tasks: Manage the day-to-day operational aspects of the quality assurance programme, including preparing, conducting, and issuing audit reports, documenting findings, observations, and critical points, and implementing corrective actions, and ensuring compliance with standards for small to mid-sized projects.
• Documentation and record keeping: Manage quality assurance documentation, review processes, deviations management, and change control processes to ensure continuous process improvement.
• Monitor and report corrective and preventive actions for non-conformance issues, communicating actions taken to Quality Assurance Manager and relevant management.
• Prepare and update Audit Register, Master Schedule, Master Record Index and SOP Vault to ensure that staff have access to most-up-to date procedures for carrying out their tasks effectively and consistently.
• Train staff on quality standards (GCP principles), procedures, and regulations as directed by the QA Manager to ensure compliance.
• Administration role:
• Implement the relevant policies and procedures in alignment with the criteria for accreditation, as well as legal and regulatory requirements.to ensure the Study Site’s adherence to accreditation, legal, and regulatory standards
• Collaborate closely with Facilities and Projects Unit, EOHS, and other departments within ILRI to ensure effectiveness and efficiency.
• Perform other delegated tasks and activities.

Qualifications

• Masters degree in biological or natural sciences.
• Familiarity with quality systems such as Good Clinical Practices.
• Certificate in Quality Auditing (e.g. Certified Quality Auditor, or relevant certificate)
• Minimum of 3 years’ experience in a similar role as quality assurance officer.
• Proficient in computer skills.
• Knowledge of animal health, animal welfare, biosecurity, bio-safety issues is preferred.

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