Biotechnologist/GMP

Key responsibilities:

• 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 required timelines
• Performs training activities of relevant areas as operator and supports others and new joiners.
• Operating, setting up and cleaning production equipment and premises for the production of liquid and freeze-dried drug forms (e.g.:compounding, parts washing, autoclaving, filter integrity testing, visual inspection)

Key requirements:

• Completed chemical / biopharmaceutical education
• 2-4 years of experience GMP environment on the shopfloor (preferably in sterile manufacturing of Drug Product)