About the role
- Responsible review of exhibit batch manufacturing records and exhibit batch packing records before execution of the batch.
- Responsible for review of process validation protocol and reports, hold time protocol and reports.
- Responsible for review of executed media fill records for regulatory submissions.
- Responsible for review and submission of executed exhibit batch manufacturing records and batch packing records.
- Responsible for review and submission of process validation reports and hold time reports.
- Responsible for review and submission of intended batch manufacturing records.
- Responsible for review and submission of product related equipment’s qualification documents.
- Responsible for review of QMS documents like Change control, deviation and CAPA.