Develop, implement, communicate, and maintain a plan to meet the Laboratory QMS in accordance with regulatory compliance and requirements.
Ensure all procedures (Pre-analytical to post-analytical) are performed in compliance with regulatory requirements.
Establish SOPs and process documentation to ensure a consistent level of service delivery across the organization.
Document Management
Formulate, manage, and deliver the documentation of policies, procedures, and systems pertaining to the Operations Department.
Maintenance and Updation of LIS- Test Master and Report template (LIS test list, reference ranges, report templates).
Maintain the document control governing the quality protocol.
Learning Content and Training Management
Creation of content, assessment, e-learning, collateral, and other training materials to ensure consistency and quality of content.
Monitors training programs and manuals to ensure that they are effective and up-to-date and makes updates as necessary.
Partner with the L&D Department to determine annual training needs, roll out annual plans, set program deadlines, and ROI.
Compliance and Accreditation
Lead, participate, and manage Compliance-related and Accreditation activities. Monitoring, auditing, and review of activities with other stakeholders.
Proper Documentation pertaining to Accreditation activities, meetings, etc.
Equipment Calibration and Preventive Management
Lead and manage timely internal/external calibration of equipment, EQAS / ILC results, AMC / insurance status of equipment and their maintenance plan across the organization.
Assisting the Laboratory Director with the setting up of and subsequent monitoring of EQAS and IQAS.
Develop, manage, and execute all QA/QC procedures of the Laboratory as per assigned timelines and parameters with Consultants.
Laboratory Onboarding
Collaborates with the Business Growth team to ensure that new business unit technical requirements are agreed to, validated via formally established processes, and met as per the standard protocol.
Able to deliver technical guidance & training to employees/ partners and ensure their competency development in driving the new laboratory operations in a self-service capacity.
Measure and monitor critical and key performance indicators of Onboarding. Work with the client/ partner and internal teams to diagnose the initial technical issues, and take corrective actions accordingly.
Assist team in setting up new laboratory infrastructure - Technical/ Non-Technical (Manpower, Equipment, Reagents, etc.). Develop and ensure implementation services procedures/policies (HR, Technical, Administrative, Quality, Customer, IT, Finance, etc.) before the launch of the laboratory.
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