Amol Shinde

• Compilation, review and maintenance of Annual Product Quality Review (APQR) for Regulatory market (US, Canada, EU, etc.).
• Review of dossiers to check registered specifications and manufacturing, packaging protocols compliance.
• Change control co-ordinator.
• Evaluate the changes for impact of variation and notify to regulatory team.
• Evaluate reviews, recommend actions and professionally communicate to sites so as to continually improve quality of products.
• Involve in handling of software such as Track-wise, SAP, LIMS, Hot-docs, Oracle system.

• Review of executed documents (BMR, BPR).
• Experience of IPQA/IPQC activities such as In-process Blend sampling, process validation in manufacturing and packaging area.
• Handling of Customer queries related to batch documents and APQR.
• Line clearance, sampling of Semi-finished goods, finished goods, etc.
• Involved in batch release activities i.e. ensuring review and compliance of all documents related to batch release and status in SAP system.
• Involvement in investigations for deviations & Market complaint received from customer/agency & to ensure the effectiveness of CAPA provided.
• Involved in investigation of online rejections and rejections during receipt of starting materials and packaging materials.

-Inprocess checks in Manufacturing and packaging area.
-Review of executed documents(BMR, BPR)
- Performing Packing validation Activity(Bottle PAck, Blister pack)