Senior Manager QA Validation

Description

JOB DESCRIPTION

The role involves reviewing and executing qualification and validation documents for equipment, facilities, and utilities. Key tasks include preparing validation protocols, coordinating with teams, ensuring c-GMP compliance, and providing training on validation processes.

Essential Functions

• Responsible to review and execution of qualification document related Equipment, Facility and Utility like Plant equipment, HVAC, Water system and Compressed air system.
• Responsible to review and execution of Re-Qualification document.
• Responsible to co-ordinate with manufacturing personnel for respective qualification / validation / Re-qualification activity form timely completion of activity.
• Responsible for preparation, review and execution of risk assessment related tEquipment, System, Facility and Process.
• Responsible for preparation and review of validation master plan tensure execution of activity.
• Responsible for preparation of cleaning validation protocol and compilation and review of cleaning validation report.
• Responsible t0 conduct sampling activity as per the approved cleaning validation protocol.
• Responsible for preparation of process validation protocol and compilation and review of process validation report.
• Responsible for preparation of packaging validation protocol and compilation and review of packaging validation report.
• To co-ordination with Quality control or Micro department for sample preparation and testing for cleaning validation, Equipment, Utilities and System qualification / validation / re-qualification study.
• Responsible to prepare and reviewed SOPs for process validation, Cleaning Validation and Qualification.
• Responsible to impart training of validation/qualification for equipment/system /utilities/process.
• Responsible to review of change control to evaluate validation requirement.
• Responsible to review of deviation and laboratory OOS related to validation.
• Responsible to check c-GMP compliance.

• Responsible to department activity planning related to process validation, cleaning validation and qualification activity.
• Responsible for Overall Validation and Qualification activities at site.
• Responsible to review of Calibration certificates and reports.
• Responsible for review & approval of Instrument specification record, calibration schedule, Preventive Maintenance schedule, validation schedule and other schedule.
• Activities other than the defined in the Job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance.

QUALIFICATIONS

• Bachelors Degree (BA/BS) B. Sc. - Required
• Bachelors Degree (BA/BS) B. Pharm - Preferred
• Master Degree (MS/MA) M. Sc. - Preferred
• Master Degree (MS/MA) M. Pharm - Preferred

• 15 years or more in 15-17 years

• Regulatory Compliance & Validation Guidelines (FDA, EMA, ICH, WHO) - Advanced
• Validation Master Plan (VMP) Development & Execution - Advanced
• Process Validation (PV) - Expert
• Cleaning Validation - Expert
• Equipment Qualification (DQ, IQ, OQ, PQ) - Expert
• Environmental Monitoring & HVAC Qualification - Expert
• Computer System Validation (CSV) & Data Integrity - Expert
• Risk-Based Validation (QbD & PAT Implementation) - Advanced
• Deviation Handling, CAPA & Change Control in Validation - Advanced
• Regulatory Inspections & Audit Readiness for Validation - Advanced
• SOP Updates & Compliance - Advanced
• Risk Assessment & Failure Mode Analysis - Expert
• Statistical Data Analysis & Process Capability - Expert
• GMP Knowledge - Expert
• GDP Knowledge - Expert
• Deviation Management - Advanced
• Change Management - Advanced
• Report Writing - Advanced
• Capability Development - Advanced
• Resource Management - Advanced
• Manufacturing Process and Equipment Understanding - Advanced
• Effective Communication - Advanced
• Continuous Improvement - Advanced
• Demonstrates leadership - Advanced