A) QMS : Identifying, handling and execution of Change Control, Deviation, OOS, OOT, Market Complaint, CAPA and Investigations.
B) General-QA
Partake in controlling, implementing, executing, Identifying, review, approval and handling of Change Control, Deviation, Market Complaints, CAPA and Investigations.
Partake in controlling, implementing, executing the activities of QA.
To check the compliance and execution of SOP's.
Online maintenance of documents and Maintenance of documentation cell.
Preparation, review and approval of SOP's.
Review of Quality Risk Management Report and coordination in Quality Risk Management activity.
Handling of desctruction and disposal documents.
Handling of online rejection documents.
C) Audit Compliance, TWD Audit Management:
Handling of GMP Audit by Customer and coordination of compliance response to Regulatory observations.
Handling of Internal and External Audits.
Tracking for Implementation and closure of identified CAPA.
Implementation and verification of Global CAPA at Site.
D) Complaint and Recall, Review of Investigation:
To aid in the investigation of customer complaints as well as the implementation of the suggested preventive actions.
Prepare and Review the customer complaint investigation report.
Involve in the investigation of recall and returned products activity of drug product.
Preparation of Mock recall protocol and Mock recall Report.
Preparation & review of FAR.
E) Qualified Trainer : Involvement in the execution of training and development programme with respect to cGMP.
F) TrackWise Digital Operation : To carry out activities in TrackWise as per the TrackWise Digital authorization.