Sr Executive / Assistant Manager - QA (IVD)
Promea Therapeutics
- Responsible for implementation of cGMP in the plant.
- Responsible for review of SOPs.
- Responsible for preparation of Quality Documents such as SMF, Quality Policy etc.
- Responsible for review and compilation of Deviations, Incidents, Change Control and Root Cause Analysis.
- Responsible for review and proper implementation of CAPA.
- Responsible for conducting and preparation of Self-inspection reports.
- Responsible for handling of Market Complaints & Product Recall.
- Responsible for providing trainings.
- Responsible for approval of Certificate of Analysis, Specifications, STPs and SOPs.
- Responsible for review of approved vendor list of Raw Material & Packing Material.
- Responsible for review of Master Packing Card, Master Formula Card, Batch Manufacturing Records & Batch Packing Records.
- Responsible for ensuring the Design and development processes meet regulatory and quality standards.
- Responsible for risk management associated with IVD products.