Assistant General Manager QA Validation

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.

Additional Responsibilities:

• 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.

Education:

• 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

Experience:

• 15 years or more in 15-17 years

Skills:

• 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

Specialized Knowledge: Licenses: