Senior Executive, QA Validation

Key Responsibilities

• To prepare and review of URS, DQ, QRM, FAT, SAT, and vendor/ supplier’s documents related to qualification.
• To execute Qualification / Re-Qualification and Validation activities of Equipment / System / Facility and Plant utilities (HVAC system, Autoclave, Isolator, Filling machine, Washing machine, Depyrogenation tunnel, UAFs, Packaging equipment, Water system, Pure steam generation and distribution system, Nitrogen/compressed air distribution system etc.).
• To perform qualification activities like air flow visualization study, Temperature mapping of Rooms/Chambers, Packaging validation, Transport validation etc.
• To co-ordinate with manufacturing, Engineering, Material Management, QC personnel and other users for respective Qualification / Validation / Re-qualification activities for timely completion of activities.
• To prepare and review Validation/ Qualification protocols and reports (IOQ, PQ, RQ, CQ, other miscellaneous qualification documents etc).
• To prepare and review process validation, cleaning validation, media fill and hold time study protocols and reports.
• To prepare and review of SOPs of Validation and Quality Assurance Department.
• To prepare and update Annual Validation Planner.
• To prepare and execute project validation master plan for commissioning and qualification of new/modified facility.
• To assess Change Control, Deviation, CAPA etc. and participate in investigation triggered through deviation, OOS, OOT or other failures.
• To involved in QMS related activities i.e initiation and review of QMS elements.
• To prepare, review and execute risk assessment activity related to equipment/ process/ facility/ system.
• To conduct sampling activities as per the protocols (Hold time, Process validation and cleaning validation etc.).
• Establish, monitor and maintain Validation function for audit readiness.
• To prepare VMP and SMF.
• To implement contamination control strategy at site.
• Complete Validation Lifecycle: URS, DQ, FAT, SAT, Commissioning, IQ, OQ, PQ
• End-to-end validation lifecycle (URS, DQ, FAT, SAT, Commissioning, IQ, OQ, PQ)
• Qualification of equipment, utilities, and facilities in sterile injectable manufacturing environments
• Process validation and cleaning validation including protocol and report preparation
• Thermal validation systems and temperature mapping studies
• Media fill validation principles and execution
• Basic risk assessment techniques (FMEA approach)
• Validation documentation management and report compilation
• Use of validation management software and electronic documentation systems
• Coordination and management of end-to-end qualification/validation activities
• M.Sc./ B.Pharm/ M.Pharm with minimum 7–9 years of relevant experience
• Hands-on experience in Qualification/Validation function within an injectable pharmaceutical manufacturing environment