MIHIR KUMAR PARIDA

• Oversee and manage sterile injectable production processes while ensuring compliance with GMP and regulatory standards.
• Supervise manufacturing operations, including aseptic filling and sterilization, to maintain product quality and safety.
• Monitor production schedules, optimize workflows, and coordinate with cross-functional teams to meet deadlines and efficiency targets.
• Ensure adherence to SOPs, validation protocols, and quality control measures for sterile manufacturing.
• Train and mentor junior staff on aseptic techniques, safety protocols, and operational best practices.
• Collaborate with quality assurance and regulatory affairs to drive continuous process improvement and compliance.
• Conduct root cause analysis and implement corrective and preventive actions (CAPA) for deviations and non-conformances.
• Maintain production records, batch documentation, and audit readiness for regulatory inspections (e.g., WHO, cGMP).
• Supervise the setup, operation, and maintenance of automated vial washing, de-pyrogenation tunnels, and filling lines to prevent contamination risks.
• Coordinate with the engineering and maintenance teams to troubleshoot and resolve technical issues in production equipment, ensuring minimal downtime.
• Implement and monitor environmental control measures (e.g., HVAC, differential pressure, and cleanroom practices) to maintain classified areas.
• Conduct in-process checks for sterility, particle load, and integrity testing of filters and vials to ensure compliance with quality standards.
• Ensure proper handling, storage, and transfer of raw materials and drug substances to maintain sterility and prevent cross-contamination.
• Participate in validation and qualification activities, including media fills, equipment validation, and process validation for sterile operations.

Company Overview: Sterile Injectables, Small Volume Parenterals with vials, ampules and PFS filling facility.

• Supervise manufacturing operations, including aseptic filling, sterilization, and packaging, to maintain product quality and safety.
• Monitor production schedules, optimize workflows, and coordinate with cross-functional teams to meet deadlines and efficiency targets.
• Ensure adherence to SOPs, validation protocols, and quality control measures for sterile manufacturing.
• Train and mentor junior staff on aseptic techniques, safety protocols, and operational best practices.
• Collaborate with quality assurance, regulatory affairs, and R&D teams to drive continuous process improvement and compliance.
• Conduct root cause analysis and implement corrective and preventive actions (CAPA) for deviations and non-conformances.
• Maintain production records, batch documentation, and audit readiness for regulatory inspections (e.g., WHO, cGMP).
• Supervise the setup, operation, and maintenance of automated vial washing, de-pyrogenation tunnels, and filling lines to prevent contamination risks.
• Coordinate with the engineering and maintenance teams to troubleshoot and resolve technical issues in production equipment, ensuring minimal downtime.
• Implement and monitor environmental control measures (e.g., HVAC, differential pressure, and cleanroom practices) to maintain classified areas.
• Conduct in-process checks for sterility, particle load, and integrity testing of filters and vials to ensure compliance with quality standards.
• Ensure proper handling, storage, and transfer of raw materials and drug substances to maintain sterility and prevent cross-contamination.
• Participate in validation and qualification activities, including media fills, equipment validation, and process validation for sterile operations.

• Company Overview: Sterile injectable, small-volume parenteral with Lyophilizer and PFS facility.
• Reviewed batch documentation including logbooks, batch records, stability records prior to release of product batches.
• Organized, analyzed and prepared data research reports in compliance with operations and record-keeping standards.
• Supervising manufacturing operations to provide better WHO and cGMP standards.
• Monitoring line clearance for control of cross-contamination.
• Ensured that all batches are produced in accordance with approved protocols and specifications.
• Developed SOPs for the manufacture of pharmaceutical products according to c-GMP guidelines.
• Provided technical support on process validation activities such as cleaning validations, equipment qualifications, and process validations.
• Monitored production operations to ensure compliance with safety regulations and quality standards.
• Assisted in troubleshooting complex problems related to manufacturing processes or equipment malfunctions.
• Evaluated existing manufacturing processes for potential improvements.

• Company over view: Oral sold drugs (Tablets, Syrups, Capsules) and Surgical spirit.
• Review documents such as BMR, SOPs, and instrument log sheets.
• Supervising manufacturing operations to provide better GMP.
• Batch processing, as per BMR, for maintaining a quality product.
• Monitoring line clearance for control of cross-contamination.
• Maintaining every process of batch preparation as per authorized SOP.
• Contributed innovative ideas and solutions to enhance team performance and outcomes.
• Managed household errands and other essential duties.
• Operated a variety of machinery and tools safely and efficiently.
• Managed time effectively to ensure tasks were completed on schedule and deadlines were met.
• Operated equipment and machinery according to safety guidelines.
• Conducted routine maintenance and repairs on mechanical systems and industrial equipment.