Abhijit Khapke

• Managed a team of 30+ employees by providing guidance, setting goals and objectives, delegating tasks, and monitoring performance.
• Implemented new technologies such as Trackwise, SAP S/4 HANA , VLMS systems .
• Creation of new manufacturing facility from the stage building design to approval for manufacturing . Global Stability Laboratory Setup., new manufacturing facility for toothpaste, OSD and manufacturing facility for Oral liquids
• Validation and qualification activities: manufacturing equipment, HVAC, water system, compressed air, cleaning validation, and process validations.
• Investigation of deviations, OOS, OOT, and market complaints.
• Represent the organization during various audits WHO, CDSCO, TMDA, PPB,NMBA .

• Worked as QMS Head
• Handled compliance with regulatory inspections, such as USFDA and MHRA.
• Review of investigation of deviations , market complaints, OOS and OOT.
• Review of process validation, cleaning validation and qualification of equipment and utilities

• Worked as a Section Head Validation and qualification ( 5 member Team)
• Involved in new OSD manufacturing facility start up.
• Performed all validation and qualification activities as per VMP.
• Faced regulatory inspections USFDA, MHRA and TGA.

· Review of qualification documents

Review of BMR, BPRs.

· IPQA activities

Sampling for process validation, cleaning validation.

• Preparation of process validation protocols
• Preparation and review of BMR,BPRs
• IPQA activities
• Sampling for Process validation, cleaning validation

• Worked as packing officer
• Lince clearance, in-process check.
• Reconciliation of PM