Qualification
M.Sc. / M. Pharma
Experience
Minimum 12-15 years
Job Location - Mulund, Mumbai.

Role Overview
Responsible for leading qualification and calibration activities for defined analytical instruments and equipment in accordance with approved schedules, procedures and QMS requirements. Responsible for QMS activities including SOPs, Change Controls, CAPA, Deviations, Investigations and effectiveness checks.
Illustrative Responsibilities
Lead and manage quality compliance activities for laboratory instrument qualification and calibration.
Coordinate with laboratory supervisors, system owners, QA, and other stakeholders for non-conformances, technical issues and escalations.
Ensure qualification, calibration, requalification and periodic activities are completed within approved schedules and applicable requirements.
Review, summarize and report analytical instrument qualification and calibration activities for appropriate review and approval.
Review qualification/calibration protocols, reports and supporting documentation for accuracy, completeness,



traceability and compliance.
Monitor overdue, failed or out-of-tolerance instruments and ensure timely escalation, investigation and appropriate disposition.
Lead investigations related to instrument failures, calibration failures, deviations and non-conformances, including root-cause analysis and CAPA.
Ensure timely implementation and effectiveness checks of CAPA and other corrective/preventive actions with proper documentation.
Coordinate with client laboratory teams and act as a technical and quality point of contact for assigned activities and escalations.
Ensure Positive Documentation Practices (GDP), data integrity and Right First Time (RFT) principles are consistently followed in the technical function.
Lead and strategize analytical and technical improvement initiatives, including reduction of recurring instrument and compliance issues.
Develop and monitor qualification/calibration schedules, resource requiremen

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