Senior Executive, QA Validation

Amneal Pharmaceuticals

Key Responsibilities

JOB DESCRIPTION

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

Qualifications

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