Deputy General Manager, QA Validation

As a Validation Specialist at our company, your role will involve ensuring that the validation system remains updated according to regulatory requirements and industry standards. You will be responsible for executing and reviewing Qualification/Re-Qualification and Validation activities for Equipment/System/Facility and Plant utilities. Your coordination with manufacturing, Engineering, and QC personnel will be crucial for the timely completion of Qualification/Validation/Re-qualification activities. Additionally, you will be preparing Standard Operating Procedures for the Quality Assurance Department and conducting sampling activities as per protocols such as Process Validation and Cleaning Validation. Key Responsibilities: - Execute and review Qualification/Re-Qualification and Validation activities for Equipment/System/Facility and Plant utilities - Coordinate with manufacturing, Engineering, and QC personnel for timely completion of activities - Prepare Standard Operating Procedures for the Quality Assurance Department - Conduct sampling activities as per protocols - Prepare, review, and execute risk assessment activities related to Equipment/Process/Facility/System - Prepare and follow up for data collection related to Annual validation planner - Submit qualification documents to RA as per requirement - Review media fill BMR - Perform IPQA activities as required - Review and approve Validation protocols, reports, QRM, SOPs, etc. - Assess and review Change Control, Deviation, CAPA, Investigation, etc. - Approve URS, DQ, and vendor/suppliers documents related to qualification In addition to the above responsibilities, you will: - Ensure readiness of validation documents and responses - Provide training on new validation procedures, regulatory updates, and equipment/system validations - Participate in Vendor Qualification and Technical Evaluation - Monitor and manage the lifecycle of validated systems for sustained compliance and performance - Maintain a cost-saving, quality improvement, time-saving, and innovative thinking approach - Demonstrate good written and verbal communication skills in the English language Education: - Bachelors Degree (BA/BS) B. Pharma - Required - Master Degree (MS/MA) M. Sc - Preferred - Master Degree (MS/MA) M. Pharma - Preferred Experience: - 12 years or more in 12 - 15 Years Skills: - Regulatory Compliance & Validation Guidelines (FDA, EMA, ICH, WHO) - Advanced - Validation Master Plan (VMP) Development & Execution - Advanced - Process Validation (PV) for Oncological Injectables - Advanced - Cleaning Validation (CIP/SIP) & Residue Limit Justification - Advanced - Aseptic Process Validation (Media Fill Studies) - Advanced - Sterilization Validation - Advanced - Equipment Qualification (DQ, IQ, OQ, PQ) - Mastery - Environmental Monitoring & HVAC Qualification - Advanced - Deviation Handling, CAPA & Change Control in Validation - Mastery - Analytical Quality Assurance - Advanced - Equipment & Facility knowledge - Advanced - Investigation - Mastery As an equal opportunity employer, we do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.,