Pradip Ghate

• Technical Project Manager and Lean Six Sigma Black Belt

  Catalent Pharma Solutions Inc

No membership or affiliation information is available.

No certification information is available.

• M.Sc., Analytical Chemistry

  Pune University

Results oriented and effective pharmaceutical expert with hands on and management experience in Production, Validation, Projects and Planning areas of pharmaceutical and biological products.

Career Highlights

· Managed aseptic filling, optical inspection, packaging of pharmaceutical products & vaccines.
· Successfully achieved the production targets in strict time bound schedules under cGMP conditions
· Thorough understanding of cGMP and regulatory requirements (FDA, TPP, WHO and other regulatory agencies). Interacted with these agencies during pre approval as well as certification and routine inspections.
· Hands-on manufacturing experience in clean room operations, sterile filling, optical inspection, packaging, and shipping.
· Active participation in developing training department and implementing training programs
· Developed and executed process improvements for cost reductions and productivity.
· Strong organizational and management skills and the ability to multitask.
· Developed and implemented MBRs, PBRs, and SOPs for new products.
· Proven experience of different validation techniques.
· Participated in Internal and external audits.
· Excellent interpersonal skills & aptitude to work as a team member.
· Proficient computer skills (MS office, Minitab, Documentum, JDE, MS Project, Visio, Track wise, Blue Mountain.
· Certified Lean Six Sigma Black Belt