Executes manufacturing activities in the area of Drug Product according to cGMP guidelines, ensuring batch execution, evaluating test results, resolving issues, troubleshoot manufacturing equipment and make recommendations for resolution.
Provides front line technical and procedural support, working with the manufacturing team.
Securing each batch is manufactured safely, on time, in compliance with the batch instructions and quality requirements
Responsible for establishing timely and with high quality the required production documentation (preparation, execution and review of batch records) or other relevant GMP documents for the assigned production area.
Supports process related investigations and assists in decision making on production issues
Supports process changes and CAPAs related to processes within req...