DSP Supervisor

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit.

Common Responsibilities:

• Monitor & confirm that the established Environment, Occupational Health, Safety and Sustainability (EHSS) practices for safe work environment are followed by self & direct reports.
• Monitor & confirm that self & direct reports adhere to the highest standards of quality, integrity & compliance for every work activity.
• Complete the assigned trainings in a timely manner and comply with the training procedure & training calendar and monitor & confirm the same for the direct reports.
• Attend all assigned mandatory trainings related to data integrity, health, and safety measures, and monitor & confirm the same for the direct reports.
• Participate in & support the trainings on procedures, protocols, and On-the-Job activities.
• Compliance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• Report nonconformities & deviations to the respective supervisor(s) and/or line manager(s).
• Participate in & support for on-time initiation & closure of deviations, investigations, CAPA and change controls.
• Preparation, revision and review of Batch Manufacturing Records (BMR), Packing and Dispatch Record (PDR).
• Issue, Checking and Review of Operations documents.
• Preparation and review of Batch Manufacturing Records, SOPs, PDRs & Protocols.
• Conduct training for all DSP employees for prepared BMRs, PDRs and related documents.
• Review of TTD’s, protocol and Quality Department Protocols related to Operations.
• Investigation of Batch failures in Operations.
• Monitor and follow good aseptic behavior inside Biologics DSP Facility.
• Support in hiring process and bringing quality workforce to develop a team that is highly respected and engaged towards departmental goals.
• Update the batch progress in PRM’s and participate in client discussions.
• Develop and implement operating methods and procedures designed to eliminate operating problems and improve manufacturing efficiency.

Safety and DI Responsibilities:

• Adhere to organizational policies & procedures on EHSS, POSH, Data Integrity and IT security, and monitor & confirm the same for the direct reports.
• Always wear the applicable PPEs and adhere to any other Environment, Health, and Safety (EHS) requirements in the workplace for individuals & lab/plant safety and monitor & confirm the same for the direct reports.
• Understand all necessary safety protocols and always follow the same to ensure safety for all and monitor & confirm the same for the direct reports.
• Proactively identify near-misses & potential incidents and communicate the same to supervisor and/or line manager or through the respective portals and disseminate learnings from those to the team members & any other concerned personnel to prevent recurrence of such events.

Specific Responsibilities:

• Provide input to Downstream for improvement of products/process.
• Develop and train high potential candidates for the next generation of leaders. Serve as a mentor to develop other leaders within the department.
• Downstream batch plan preparation as per campaign schedule.
• Supervise commissioning and qualification activity of Biologics DSP Facility related equipment.
• Preparation of micro batch schedule and shift planning for day-to-day activities.
• Monitor and follow good aseptic behavior inside the Biologics DSP Facility.
• Support in audit and audit closure points.
• Involve in shipment of samples / final product as per packing and dispatch record.
• Prepare, revise and review of general validation protocols and reports, equipment requalification protocols, Installation, operation and performance qualification protocols and related documents.
• Supervise Downstream activities of buffers preparation, Harvest, purification and final filtration,
• Calibration of operations equipment.
• Monitoring and process control of specific operations of downstream.
• Review of Quality  department protocols related to Operations.
• Support all site audits, inspections and client/consultant visits.
• Compliance to current good manufacturing practices.

Facilitate & monitor the process with Engineering and Maintenance to troubleshoot process problems and identify solutions that reduce downtime in a cost-effective manner.