Executive, Quality control(Baxter)

Roles and Responsibilities

1.To prepare specifications, Standard Test Procedure (STP) and formats for Certificate of Analysis (COA), Analysis report and Calculation sheet based on reference ADL documents.
2. To update addendum of index for new specification and update Specification index on quarterly basis.
3. To provide COA based on QC requirement.
4. To initiate DCR/CCM for updating of specification, Standard Test Procedure (STP) and calculation sheet.
5. To ensure availability of updated calculation sheet in Controlled Form System.
6. To initiate departmental NCR if any.
7. To close DCR/CCM/ NCR/CAPA task on timely manner.
8. To ensure that all document records are in line with cGMP and regulatory compliance.
9. To prepare/update departmental Standard Operating Procedure (SOPs).
10. To review and release and set effective date of documents in TcU
11. To provide Training for new TcU user.
12. To link new documents in respective department in CFS.
13. To maintain data of document inventory and ensure all documents well-arranged and maintained in central record room as per SOP.