Hardik Sheth

I have 13 years of experience in pharmaceuticals organization as microbiologist.

• Operation and Validation of microbiological analysis methods. (Sterility test, Bio-burden, Bacterial Endotoxin Test, Microbial Limit Test, Preservative efficiency test, Antibiotic assay).
• 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.

Master of science (Microbiology)