Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
• Scheduling, planning, executing, monitoring and control of shift based manufacturing operations.
• Responsible for the Upstream operations for the manufacturing of cell culture processes & Inoculum Operations for the production of monoclonal antibodies
• Preparation and review of cGMP documents like SOP, batch records, checklists, protocols and reports.
• Handling of single use bioreactors, good in Asceptic Operations handling.
• Maintaining the equipment and facility in a state of compliance with effective calibration, preventive maintenance and validation programs.
• Organizing workflow by assigning responsibilities and preparing work schedules to meet the production targets.
• Managing and mentoring a small group of experienced employees for downstream operations.
• Analysing and resolving equipment, process and operational problems in an effective and timely manner.
• Coordinating with cross functional teams for the smooth functioning of operations to achieve the departmental objectives.
• Facing internal and external audits, ensuring highest level of compliance for cGMP and EHS norms
Pharma Manfacturing with experience in aseptic operations, biosimilars, bioreactors handling
B.Tech
To apply for this job please visit career10.successfactors.com.
