Assistant Manager, QA Validation at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

30 Jun, 26

Salary

0.0

Posted On

01 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Validation, Qualification, Process Validation, Cleaning Validation, Risk Assessment, Temperature Mapping, SOP Preparation, Project Management, Deviation Investigation, Change Control, Audit Readiness, Contamination Control, Thermal Validation, Media Fill Validation, Equipment Qualification

Industry

Pharmaceutical Manufacturing

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

Responsibilities

The Assistant Manager, QA Validation is responsible for reviewing qualification documents and conducting validation activities for equipment, systems, and facilities. This includes coordinating with various departments to ensure timely completion of validation activities and preparing necessary protocols and reports.