A pharmaceuticals company located in Gujarat is seeking a professional to ensure cGMP compliance and oversee manufacturing processes. Responsibilities include preparing and reviewing related documents, supervising batch manufacturing activities, organizing staff training, and implementing risk management strategies. The ideal candidate will have a strong focus on quality assurance and the ability to manage projects effectively in a compliant environment.
Responsibilities
Ensure cGMP compliance as per guidelines.
Prepare and review relevant manufacturing documents.
Execute and monitor batch manufacturing documentation.
Implement risk management strategies in production.
Troubleshoot and improve manufacturing processes.
Plan and execute manufacturing activities per schedule.
Organize training for staff members.
Manage project and resources effectively.
Oversee technology and product transfer activities.
Supervise manufacturing activities in compliance with cGMP.
Job description
To ensure cGMP compliance requirement as per Schedule M, WHO, other MO and regulated market guideline.
Prepare and review of SOP, test protocols, reports, BMR/BPR/MFR, qualification protocol/report and other relevant document required for execution of manufacturing.
Execute and monitor batch manufacturing and packing related all documents like batch record, logbooks, etc.
Risk management and mitigation strategies for product manufacturing/packing activities.
Execute trouble shooting, process improvisation and manufacturing activities as and when required.
Plan and execute manufacturing/packing activities as per product planning schedule.
Organizing and impart trainings to the staff members.
Project and resource management.
Ensure smooth technology transfer and product transfer activities.
Supervise the manufacturing/packing activities in line with cGMP requirement.