AM / DM - Quality Control

1.Pharmacopeial Updation and notification of updated to all India regions.

2.Evaluation of Low molecules nitrosamine impurities and NDSRI of all commercial products

3.Evaluation of post approval changes and assessment of Nitrosamine, Element impurities and residual

solvent

4.Review of justification of audit trail related with empower and other than empower software of QC and

ARD.

5.Preparation/Review of Method Transfer, Method Verification protocol and report in QC.

6.Oversee stability samples as per approved stability protocols, including charging, retrieval, and

documentation.

7.Oversee the movement of stability samples related charging and withdrawal form stability chambers.

8.Troubleshooting in LIMS.

9.Evaluation and execution of GLP related activity for Metsera Project.

Assessment of Vendor notification

1.ANDA and Post approval regulatory submission

2.Regulatory submission of International, Latum and EU Market

3.Assessment of CFT Change control.

4.Initiation and assessment of Change control for post approval material/components and finished

products

5.Review of specification and MOA (Excipients, finished products and packaging materials etc.)

6.Review of QRM, APQR, Hold time, process validation, cleaning validation protocol and reports

7.Arrangement of three lots for vendor qualification program and preparation of vendor qualification testing

report.

8.Review of DDP/DHF and Miscellaneous protocols and reports.

9.Review Quality Control (QC) Standard Operating Procedures (SOPs).

10.Review instrument logbooks and raw data for raw materials, packing materials, miscellaneous

materials, in-process samples, finished products, and water

analysis.

11.Maintain workplace cleanliness and ensure compliance with Good Laboratory Practices (GLP).

12.Prepare study protocols related to laboratory activities.

Documentation

13.Prepare vendor qualification reports and comparison reports; summarize Amneal test results and vendor test reports.

14.Coordinate with the ARD department for new material specifications and methods of analysis for APIs, excipients, and packaging materials; prepare related specifications and methods of analysis.

15.Prepare indents as per material and product requirements.

16.Review specifications for raw materials, packing materials, in-process samples, finished products, and stability protocols as required.