Sr 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

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