Executive QA( calibration)

Sahajanand Medical Technologies; Telangana; On-site; INR 600,000 - 900,000; Full time

Job summary

Sahajanand Medical Technologies in Telangana, India, is seeking a calibration and validation engineer to plan, coordinate, and execute calibration activities for measuring, monitoring, and test equipment, in line with approved procedures and schedules.

You will prepare validation protocols, reviews, URS, risk assessments, and validation reports, while coordinating internal and external calibration efforts to meet due dates. Strong documentation and compliance with ISO standards are required.

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.

Job description

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.