Executive QA( calibration)

Roles & Responsibilities

• Plan, coordinate, and execute calibration activities for measuring, monitoring, and test equipment as per approved procedures and calibration schedules.
• Prepare and execute validation protocols, reports, and related documentation.
• Coordinate internal and external calibration activities and ensure calibration is performed within the defined due dates.
• Maintain and update instrument master lists, calibration records, equipment history cards, and calibration status.
• Perform equipment qualification (IQ/OQ/PQ) and validation activities for manufacturing, laboratory, and utility equipment.
• Prepare and review URS, risk assessments, qualification protocols, validation protocols, and validation reports.
• Prepare & support clean room validation, packaging/sealing validation, and revalidation activities, as applicable.
• Develop and execute validation plans, test cases, acceptance criteria, and sampling plans based on applicable requirements.
• Ensure calibration and validation activities comply with ISO 13485, ISO/IEC 17025, and internal QMS procedures.
• Evaluate calibration results and investigate out-of-tolerance (OOT), out-of-calibration, and calibration failures.
• Initiate and support deviation, CAPA, change control, and impact assessment related to calibration and validation activities.
• Review calibration certificates from external laboratories for traceability, measurement results, uncertainty, acceptance criteria, and compliance.
• Ensure calibration standards and reference instruments have valid traceability to national/international standards.
• Coordinate with Production, QC, QA, Maintenance, Engineering, and external vendors for calibration and validation activities.
• Maintain validation/calibration documentation and ensure data integrity, traceability, and document control.
• Support internal, customer, certification, and regulatory audits by providing calibration and validation records and technical justifications.
• Identify gaps in existing calibration and validation practices and implement continuous improvement actions.
• Monitor calibration/validation schedules and prepare periodic status reports and KPI/MIS reports for management.
• Provide technical guidance to junior team members regarding calibration methods, equipment qualification, validation execution, and documentation.