Executive - Quality
24 hours ago
Executive - Quality
**Job Responsibility:
- **
Quality Assurance Plan
- 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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