Mahesh Kurde

Preparation and Review of Process Validation protocol and reports.

Change control Management in Trackwise QMS software.

Preparation and review of APQR.

Review of Master BMR and BPR in SAP system.

Responsible for Handling of Deviation,CAPA in Trackwise system.

Preparation and Implementation of SOP in DMS system.

Review of executed BMR and BPR.

• Compliance oversight in production areas.
• Release of finished products.
• Implementation of QMS systems and confirms that product is getting manufactured at site as per cGMP requirement.
• cGMP compliance at CMO sites for new and current products.
• Review of Process validation protocols, Master documents.
• Perform audit at CMO sites.
• Follow up and tracking of CAPA.
• Preparation and maintenance of audit planner
• Review of Change control, Deviations and other QMS documents.
• Management of Customer complaints in Trackwise system.
• Review of Annual Product Quality Review reports.
• Management of stability study program and review of stability study summary reports.
• Review and approval of Artwork in Artwork Management system.
• Preparation and Review of Quality metrics.
• Handling of Packing and Raw material rejections.
• Review of technology transfer documents.

• Preparation,review and approval of SOPs.
• Training co-ordinator.
• Handling of Change Control.
• Review of Qualification Documents.
• Issuance of logs,formats,checklists,reports,protocols.
• Review of complete set of BMR & BPR.

• Preparation, review and approval of SOPs.
• Handling of Change Control.
• Training related activities.
• Issuance of Documents.
• Review of Qualification Documents.
• IPQA activities

• Preparation, review and approval of SOPs.
• Handling of Change Control.
• Training related activities.
• Issuance of Documents.
• Review of Qualification Documents.
• IPQA activities.

• Ensure the adherence to cGMP
• Involving in sampling activity of bulk & finished product.
• Line clearance for various Manufacturing activities
• Involving in monitoring of Validation Batches & sampling.
• Perform Quality in process checks from Dispensing to packing.
• Issuance & review of B.M.R, S.O.P's,RM specification.
• Knowledge about SAP
• Responsible for training of personnel.
• To review all quality documents & logs on monthly basis.
• To withdraw routine sample at the stage of mfg and transfer to Q.C for analysis.
• Responsible for handling of rejected raw material.