Key Responsibilities 1. Strategic Operations Management Lead and manage daily operations across departments: Purchase, Store, Production, QA, QC, and Export Coordination. Implement efficient production planning and scheduling to meet customer demands and reduce downtime. Optimize resource utilization and reduce wastage while maintaining cost-effective operations. 2. Data Analysis & Systems Implementation · Perform in-depth data analysis of production, quality, inventory, and compliance metrics. · Identify patterns, root causes of inefficiencies, and opportunities for improvement. 2. Quality & Compliance Ensure all processes align with ISO 13485:2016, CE, FDA, and country-specific regulatory requirements. Manage internal and external audits. Oversee document control, batch manufacturing records, change controls, CAPA, and product traceability systems. 3. Process Improvement & Efficiency Analyze operational KPIs and production metrics to identify bottlenecks and inefficiencies. Drive continuous improvement initiatives (Lean, Six Sigma, Kaizen) to enhance productivity and compliance. Implement and monitor Standard Operating Procedures (SOPs) across departments. 4. Cross-Functional Coordination Facilitate seamless communication and collaboration between departments. Support Sales and Export teams with production updates, dispatch timelines, and product availability. Coordinate with Engineering, and Maintenance for product and process improvements. 5. Procurement & Inventory Management Monitor raw material procurement and vendor performance. Ensure efficient stock control, storage practices, and timely replenishment of critical inventory. Maintain accurate purchase forecasts and align procurement with production schedules. 6. Reporting & Review Prepare and submit daily and weekly reports to top management on operations status, KPIs, compliance, and non-conformities. Lead operational review meetings and ensure action plans are followed and closed. 7. Team Leadership Supervise and mentor department heads and operational staff. Foster a culture of accountability, collaboration, and professional development. Set performance targets and conduct regular evaluations. Desired Skills & Qualifications Proven experience in operations management within medical device or pharmaceutical manufacturing. Strong knowledge of ISO 13485, CE marking, and regulatory compliance. Excellent analytical, problem-solving, and decision-making skills. Hands-on experience with ERP systems and production software. Strong interpersonal and communication skills for cross-departmental coordination. Ability to work under pressure and manage multiple priorities. Job Type: Full-time Pay: ₹30,000.00 - ₹45,000.00 per month Benefits: Provident Fund Schedule: Day shift Supplemental Pay: Yearly bonus Ability to commute/relocate: Vatva Gidc, Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (Preferred) Experience: Operations: 3 years (Required) Work Location: In person

QA RA Executive Position: 1 Reports to: Managing Director Job Location: Plot No.4002,GIDC Vatva,Ahmedabad Qualification: M.sc., B.Pharm M.Pharm or Equivalent Experience: 1-4 year Pay and perks: Best in the industry Roles and Responsibilities: 1. Prepare, review, and update standard operating procedures (SOPs), work instructions, and quality manuals. 2. Ensure that all quality documents are prepared, maintained, and controlled in line with regulatory requirements. 3. Prepare detailed internal audit reports highlighting observations, non-conformances, and opportunities for improvement. 4. Conduct Management Review Meetings (MRM) to present audit findings, KPI/KPR performance, and areas for system improvement. 5. Propose and implement corrective actions based on audit findings to improve system efficiency and achieve maximum output with accuracy 6. Issue BMRs to production departments, ensuring accuracy and alignment with the production schedule. 7. Review completed BMRs for correctness, completeness, and adherence to established procedures and regulatory requirements. 8. Approve finalized BMRs for product release after ensuring all critical parameters and documentation meet quality standards. 9. Final Inspection for Batch release 10. Ensure all QA activities align with ISO 13485:2016 and EU MDR CE requirements. 11. Maintain documentation and records for regulatory compliance, including device master records (DMRs), technical files, and risk management documentation. 12. Random Inspection of process at different stages. 13. Develop and maintain a calibration schedule for all equipment and instruments used in production, quality control, and testing. 14. Ensure timely calibration of equipment to maintain accuracy and reliability in processes. 15. Oversee validation activities for equipment, processes, and systems, ensuring compliance with regulatory and company standards 16. Ensure that product labels are finalized in compliance with EU MDR Guidelines and any specific buyer requirements. 17. Maintain comprehensive and accurate records of all QA-related activities, including calibration, validation, and compliance documentation. 18. Conduct training sessions for employees on QMS requirements, ISO 13485, EU MDR, calibration, and validation procedures. 19. Ensure that employees are aware of their responsibilities in maintaining product quality and regulatory compliance. 20. Initiate and manage Corrective and Preventive Actions (CAPAs) to address identified issues and prevent recurrence. 21. Identify areas for improvement in QA processes and recommend enhancements to ensure operational excellence. 22. Strong analytical and problem-solving abilities. 23. Look after Primary secondary and bar code for appropriate artwork of packaging material Job Type: Full-time Pay: ₹15,109.77 - ₹18,021.45 per month Benefits: Cell phone reimbursement Schedule: Day shift Work Location: In person

QA RA Executive Position: 1 Reports to: Managing Director Job Location: Plot No.4002,GIDC Vatva,Ahmedabad Qualification: M.sc., B.Pharm M.Pharm or Equivalent Experience: 1-4 year Pay and perks: Best in the industry Roles and Responsibilities: 1. Prepare, review, and update standard operating procedures (SOPs), work instructions, and quality manuals. 2. Ensure that all quality documents are prepared, maintained, and controlled in line with regulatory requirements. 3. Prepare detailed internal audit reports highlighting observations, non-conformances, and opportunities for improvement. 4. Conduct Management Review Meetings (MRM) to present audit findings, KPI/KPR performance, and areas for system improvement. 5. Propose and implement corrective actions based on audit findings to improve system efficiency and achieve maximum output with accuracy 6. Issue BMRs to production departments, ensuring accuracy and alignment with the production schedule. 7. Review completed BMRs for correctness, completeness, and adherence to established procedures and regulatory requirements. 8. Approve finalized BMRs for product release after ensuring all critical parameters and documentation meet quality standards. 9. Final Inspection for Batch release 10. Ensure all QA activities align with ISO 13485:2016 and EU MDR CE requirements. 11. Maintain documentation and records for regulatory compliance, including device master records (DMRs), technical files, and risk management documentation. 12. Random Inspection of process at different stages. 13. Develop and maintain a calibration schedule for all equipment and instruments used in production, quality control, and testing. 14. Ensure timely calibration of equipment to maintain accuracy and reliability in processes. 15. Oversee validation activities for equipment, processes, and systems, ensuring compliance with regulatory and company standards 16. Ensure that product labels are finalized in compliance with EU MDR Guidelines and any specific buyer requirements. 17. Maintain comprehensive and accurate records of all QA-related activities, including calibration, validation, and compliance documentation. 18. Conduct training sessions for employees on QMS requirements, ISO 13485, EU MDR, calibration, and validation procedures. 19. Ensure that employees are aware of their responsibilities in maintaining product quality and regulatory compliance. 20. Initiate and manage Corrective and Preventive Actions (CAPAs) to address identified issues and prevent recurrence. 21. Identify areas for improvement in QA processes and recommend enhancements to ensure operational excellence. 22. Strong analytical and problem-solving abilities. 23. Look after Primary secondary and bar code for appropriate artwork of packaging material Job Type: Full-time Pay: ₹15,109.77 - ₹18,021.45 per month Benefits: Cell phone reimbursement Schedule: Day shift Work Location: In person