Debajyoti Deb Email & Phone Number

Mumbai, MH, IN

Hyderabad, Telangana, India

Responsible for Manufacturing Compliance

Vadodara, Gujarat, India

• Responsible for site Process Validation.
• Responsible for site Cleaning validation.
• QA representative in evaluation of process engineering w.r.t to quality.
• Coordinator for the introduction of New molecules into the site.
• Responsible for the handling of change control and deviation related to new molecules.
• Preparation and review of SOP.

Kalyani, W.B

• Coordinator for Change control management.
• Coordinator for Deviation management.
• Preparation and review of SOP’
• Review of process validation protocols and reports.
• Review of cleaning validation protocol and report.
• Performed International vendor audits for key starting materials.

Goa, India

• Responsible for managing IPQA (manufacturing) activities.
• Review of planned preventive maintenance of plant.
• Carry out Line clearance, In process Test, Sampling activities, BMR Review etc.
• Responsible for review of CAPA in shop floor.
• Preparation and review of SOP’s.
• Carry out Unit operation, conducting an internal audit/self inspection (cGMP/Quality) of company sites and ensuring compliance to cGMP/corporate Global Quality Standards /regulatory standards etc.

Goa

• Responsible for Shop floor management/Planning- Allotment of work, Arrangement of shift schedules, Communication & follow up with other depts. for relating issues etc.
• Responsible for Shop floor Handling- Carry out Line clearance, In process, Sampling activities, Batch record review etc.
• Responsible for final review before Batch release, Approval/Rejection of online materials, Approval of master specimens etc
• Responsible for review & approval of Master Batch records, ANDA Batch records, Review & Approval of protocols (Qualification, Pack validation, Non routine study protocol) etc.
• Responsible for carry out Equipment Qualification, Review of protocols & Reports.
• Responsible for review of CAPA in shop floor.

B.Pharm

M.Pharm