Executive/Sr. Executive QA Third Party Operation-With Top Pharma MNC Co. Mumbai.

1.

Global Trackwise change Control, Deviation and CAPA Management

a) Logging of the change control, Deviation and CAPA in the Trackwise.

b) To monitor the change control, Deviation and CAPA till Closure. Ensure no overdue in the approval of change controls, deviations and CAPA in Trackwise.

c) Evaluation of Change Controls

• Evaluate the Change controls related to

• Batch manufacturing records

• Batch packing records

• Change associated with Materials, Suppliers

• Change associated with process and equipment.

• Specifications and method of analysis of raw & packing materials

• Specification and method of analysis of finished products

• Stability protocols

•Line by line review and comparison of the existing and the proposed documents associated with the change control.

•Ensure all supporting documents to justify the changes are available and all changes are evaluated appropriately.

•Progressing and monitoring the change controls throughout the lifecycle.

d) Investigations / LIRs / OOS & OOT / Deviations

•Review the investigations provided by the Suppliers related to

•Deviations

•Laboratory Investigations, OOS & OOT related to releases & Stability

•Ensure proper investigation tools have been used to identify the root cause / probable causes.

e)Periodic training and Trackwise update training to the users.

f)Train the new hires and get access from Trackwise system owner.

g)Publish monthly KPI data related to Trackwise.

2.

SOP preparation/Document Management

a) Preparation and revision of Quality System SOP’s

b)To archive and retrieve the documents as per the required retention times.

3.

Batch Record Review:

a)Review of the Certificate of Analysis and the Certificate of Conformance.

b)Review of the batch manufacturing and packing records.and the supporting records like API COA, Inprocess results, packaging labels, etc.,associated with validations, new products and periodic batch record reviews for Qualified sites.

c)Review of the Shipping Temperature reports and if unsatisfactory forward to the investigation team for logging the deviation in the Trackwise.

d)Trending of the temperature excursions and share the data with the logistics team for investigation.

e)Review and ensure that there are no open deviations and change controls impacting the release of the batches.