Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures.
Prepare, review and approval of technical documents, procedures, OOS/OOT, CAPAs, change control, deviations, metrics, Incident reporting, etc.
Demonstrate a high level of technical leadership, collaboration, coaching and mentoring to facilitate the team in becoming a high-performance organization and ensuring timely delivery of projects.
Preparation of SOP’s and trend analysis of water and environmental monitoring.
Water System, yearly Summary and trend preparation.
Validation of utilities such as AHU System, Water System.
Actively pursue development opportunities to increase the skill set and experience within the group through continuous training, job rotation, cross-functional training etc.,
Microbiological analysis of RM, PM, FP & in process samples.
Qualification and Re-validation of equipments like Autoclave, Laminar air flow unit, Dry Heat Sterilizer, Cleaning validation.
Environmental monitoring by Settle plate, Surface test, air sampling. Documentation of all routine analysis.
Review of routine analysis data.
Documentation of all routine analysis, validations and calibration as per regulatory requirements.
Preparation and analysis of monthly, quarterly and yearly trends.
