Compliance and Quality Assurance Coordinator

To provide quality support for planning, conducting and documenting all project – related activities in conjunction with Project Managers and assigned Study team (Logistics, Laboratory), ensure their adherence with clinical protocol, Analytical Plan, MICS QMS documentation as well as the contractual agreements.

• Reviewing and performing internal audits or the study specific audits, included by not limited to revision of study specific documents.
• Ensuring local processes quality and compliance control to perform in-process audits when internal issues are identified.
• Collaborating with Affiliate and subcontracted laboratories with regards to changes in laboratory processes, reference values and/or methodology to ensure the availability of supporting records of such changes.
• Supporting in administrating all quality system documentation: SOPs, instruction, forms.
• Participate in preparing and archiving QMS documents.
• Supporting in monitoring all main processes in MICS by performing internal audits, analyzing nonconformities and implementing corrective actions.
• Supporting in performing external audits of third party vendors/affiliate labs/ subcontracted laboratories.
• Solving quality issues and queries from clients.
• Participation in remote or on site audits.