Executive

About the role

"• To lead the technology receiving activities and QMS related activities at manufacturing plant. To lead technology-receiving activities to receiving processes from upstream process development to manufacturing and/or between multiple manufacturing sites. This includes developing and maintaining key SOPs, manufacturing records to support compliance with quality management and regulatory submissions.

What you'll do

• Lead technology-receiving activities to receiving processes from upstream process development to manufacturing and/or between multiple manufacturing sites. This includes…
• Lead alternate vendor batch execution, process improvement, change in batch size, troubleshooting at shop floor
• Coordinate the development of the manufacturing process with the R&D by keeping in mind scale-up issues, process specifications
• Review and approve documents like SOP, Batch Manufacturing Record, Sampling Protocol, hold time study protocol/ report, stability study protocol/report
• Provide technical support for change management, investigations of deviations, OOS, Market complaints, CAPA identification and QMS related activities at plant

What you need

• Regulatory affairs
• ISO 9001
• SOP writing
• Any graduate