Execute manufacturing activities in the area of Drug Product according to cGMP guidelines, ensuring batch execution, evaluating test results, resolving issues, troubleshooting manufacturing equipment, and making recommendations for resolution.
Provide front‑line technical and procedural support while working with the manufacturing team.
Secure that each batch is manufactured safely, on time, and in compliance with batch instructions and quality requirements.
Establish timely and high‑quality production documentation (preparation, execution, and review of batch records) or other relevant GMP documents for the assigned production area.
Support process‑related investigations and assist in decision‑making on production issues.
Support process changes and CAPAs related to processes within required timelines.
Perform training activities for relevant areas as ...