Job Description

Responsibilities:

VALIDATION

• Compliance of Qualification and requalification of Equipment's, Utilities and Facility.
• Review and Approve of Qualification Protocol and Qualification Report.
• Review and Approve of QMS related activities.
• Reporting and investigation of Deviation with operations.
• Review authority for other QA documents such as Master Plans, Risk Assessment Reports, and Audit Response etc.
• Implementation of global quality standard.
• Planning and arranging for internal and external departmental support of quality assurance activities as directed in approved protocols, quality systems or procedures.
• Escalation of compliance concerns.
• Instrument Calibration and Drawings related activities
• Provide required support for all qualification and validation related activities during internal / external inspection.

• Review and approval of QMS (Deviations, Change Control, CAPA, incidences, investigations etc.) related to computerized systems.
• Work in partnership with the site cross functions and corporate functions for Audit readiness for Validation and lifecycle management for all internal/external and regulatory inspections.
• Draft response and comply internal/ external audit observations for computerized systems.
• Lead the assessment, tracking of remediation and monitoring of identified actions as part of various corporate initiatives.
• Lead to present/discuss and define way forward for fast track remediation of open action items related to Qualification in site QRB meetings.

Sun Pharmaceutical Industries