Job Description

To review of URS, DQ, QRM, FAT, SAT, and vendor/ supplier’s documents related to qualification.

To conduct sampling activities as per the protocols (Hold time, Process validation and cleaning validation etc.).

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 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 prepare, review and execute risk assessment activity related to equipment/ process/ facility/ system.

To work as department/location training coordinator.

Responsible for QMS related activities.

Establish, monitor and maintain Validation function for audit readiness.

To prepare VMP and SMF.

To implement contamination control strategy at site. Exposure Individual will gain experience in:

Complete Validation Lifecycle: URS, DQ, FAT, SAT, Commissioning, IQ, OQ, PQ

Equipment, Utility, and Facility Qualification in sterile injectable plants

Process Validation and Cleaning Validation activities including protocol and report preparation.

Thermal Validation System handling and temperature mapping studies

Media Fill validation principles

Risk assessment basics (FMEA concept)

Validation documentation preparation and report compilation

Exposure to Validation Management Software / Electronic Documentation Systems

Leadership and management of Qualification/Validation activities

M.Sc. (Microbiology / Chemistry / Biotechnology)/B.Pharm / M.Pharm with minimum 9 years of experience

Experience in Qualification/Validation department (Injectable Facility)