Harshad Kumar Chokhara

• Handled shift in-charge duties for fermentation process and area cleaning daily.
• Maintained area cleaning and day-to-day cleaning tasks to uphold standards.
• Coordinated safe area cleaning management to cut accident risks significantly.
• Collaborated with team members to meet target results consistently.
• Managed complaints calmly through clear communication and solution-focused problem-solving.
• Maintained clean and safe working environments to minimise accident risks.
• Achieved service time and quality targets through steady follow-through.
• Identified issues by analysing information and providing practical solutions.
• Resolved customer queries using effective communication and step-by-step guidance.
• Demonstrated consistent hard work and dedication to improve operations outcomes.
• Trained and mentored employees to maximise team performance effectively.
• Met schedules through strong planning and coordination skills daily.
• Prepared SOPs, BMRs, and managed change control and deviations handling.
• Ensured audit compliance across SOP preparation, BMR preparation, and changes.
• Worked as departmental training coordinator to support day-to-day learning.

Responsible for the upstream area as an area in charge.

• Cell disruption using a microfluidiser or homogeniser.
• Responsible for the fermenter revalidation activity.
• Optimisation of fermentation parameters and media composition, development of feeding strategies for yield improvement, identification of critical process parameters, and scale-up following strict GMP regulations.
• Upstream process development for the production of protein and polysaccharide-based bacterial vaccines from wild-type and recombinant strains at 3-350L scale in a GMP-qualified facility.
• Continuous monitoring of fed-batch fermentation runs, right from inoculation to harvesting and clarification, for the production of the desired polysaccharide and protein.
• Responsible for planning, managing, and monitoring the day-to-day activities of the production campaign.
• Responsible for the preparation and filling of batch records, log books, data records, and training documents.
• MCB and WCB vial preparation for WCP and Protein D vaccine.
• Supervised junior officers and operators, providing training and mentorship to develop their skills.

• Adherence to Standard Operating Procedures, GMP, and product specifications. Authorised to operate fermenters, NDVs, MPVs, CIP tanks, etc. through the DCS/SCADA system. Responsible for cleaning the equipment or accessories as per the equipment cleaning checklist, approved procedures.
• Responsible for all the manufacturing operations as per the respective BMR, checklist, routine monitoring, or recording of documents as per approved procedures.
• Maintenance of production-related documents and quality records.
• Imparting training on SOPs, IOPs, BMR, ECC, and process-related aspects to maintain quality and consistency in production.
• Responsible for clearance during product changeover, including all validation, qualification, and audit preparedness.
• Coordination with other departments related to production activities. Handling of procedures, and shut down and start up in the production facility.
• Maintenance of production equipment and instruments in coordination with the Instrumentation, Engineering, and Maintenance Department.
• Handling batch failures related to fermentation products.
• Responsible for performing the passivation activities.
• Data entry and review of quality records.
• Adherence to safety, health, and environment norms and pollution control.
• To follow the established procedures and policies of the company pertaining to the EHS management system.
• Handling of hazardous, non-hazardous, and solid or liquid waste materials.

• Documentation (BMR), germinator preparation, and inoculation.
• Seed fermenter sterilisation and germinator transfer in seeds. Fermenter preparation and induction.
• Monitoring and control of in-process parameters related to the fermenter process, such as temperature, pressure, dissolved oxygen, pH, and RPM.
• Substrate preparation and handling the west folia.
• Transfer line sterilisation and dosing vessel preparation.
• Preparation of buffer solution, cleaning of fermenter. CIP, SIP, and filter integrity tests check sterility.
• Working experience includes 5L, 20L, 25L, 50L, 1KL, 5KL, and 16KL.
• Troubleshooting various problems related to fermenters and equipment handling to efficiently minimise errors.
• Products: PRA, PRB, etc. ESIP, CIP, FSIP, etc.
• Maintained clean, safe working environments to eliminate accident risks.
• Identified issues, analysed information and provided solutions to problems.
• Men's power control.
• Follow the C-GMP, WHO, and USFDA.

• QC and R&D enzyme assay analysis of phytase, protease, and lipase.
• Isolated and identified rhizospheric bacteria from the environment, which possess plant growth-promoting mechanisms. This gave the company four new products, thereby increasing their profits. Maintained research protocols for compliance with the Fertilizer Control Order, India.
• Managed bacteriologist and mycology stocks.
• Maintained stock levels of laboratory supplies and handled all equipment, resulting in cost savings for the lab.
• Maintaining bacterial and fungal cultures on agar plates and broths.
• Enumeration of biofertilisers (bacteria and fungi) from given samples and liquid samples.
• Isolation and identification of bacteria using biochemical tests.