The Program
ILRI is in the process of developing a Contract Research Organization (CRO) arm to provide services to internal and external research projects utilizing its animal research facilities. To ensure the delivery of efficient and high-quality research in line with compliance (VICH GCP) and timelines, ILRI is looking for an experienced person in charge of quality assurance and compliance of all CRO activities.
Key Responsibilities:
Ensure compliance to relevant guidelines, Controlled Documents, and study plans/protocols by performing:
Study specific audits on the critical phases identified for a study
Audits on study plans/protocols and final study reports, including amendments
System/facility and process audits as per audit plan.
Directed audits as requested and delegated by Head of Quality Assurance
Perform Subcontractor and Outsourced Company evaluations and audits as requested and delegated
Prepare and issue audit reports and document findings, observations, and critical findings
Perform reviews of Controlled Documents.
Develop, recommend, and monitor corrective and preventive actions and communicate to relevant management
Manage Controlled Document deviations and Change Control Plans
Manage the Master Schedules
Support Sponsor audits and Regulatory inspections performed at ILRI
Support in the training of personnel in GLP and GCP principles and of Quality Assurance SOPs
Maintain internal training compliance
Manage the department’s compliance to accreditation, legal and regulatory requirements
Manage reporting employees with the intent to promote a culture that reflects the organization’s values, encourages good performance and rewards productivity
Observe the correct reporting, remedial and corrective actions to be followed by following set instructions and procedures to report and correct any non-conformance issues.
Execute other tasks and activities as delegated by the supervisor
Work in close collaboration with ILRI’s EOHS (Environmental, Occupational Health & Safety) department
Requirements
MSc. or equivalent qualification in biological or natural sciences; and
Sound knowledge of GLP and GCP quality systems
At least 5 years’ relevant experience
Expertise in animal health, animal welfare, biosecurity, bio-safety issues, and the 3Rs (Refine, Replace and Reduce) concept associated with animal health research.
Apply via :
www.ilri.org
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