Pradipkumar Amulakhbhai Patel

• Executing CMO and CDMO programs

Scaled and validated manufacturing processes for registration batches and addressed regulatory queries.
Optimized plant capacity utilization through effective debottlenecking strategies.

• Managed site transfer projects to ensure seamless transitions and minimal operational disruption.
  Developed alternative vendor strategies to enhance supply chain flexibility and robustness.
  Executed new product launch projects, driving market entry and revenue generation.
  Contributed to USFDA audit compliance initiatives, maintaining regulatory standards and adherence.

• Facilitated technology transfer of solid oral dosage form from lab scale optimization to new product launch and site transfer

Reviewed process validation protocols to ensure compliance with standards.
Executed validation batches while adhering to established timelines.
Analyzed results from validation reports to identify trends and discrepancies.
Investigated deviations, market complaints, and out-of-specifications or out-of-trends issues.
Contributed as a member of technology receiving team, transitioning from Formulation & Development team.
Developed corrective actions based on analysis of results and investigations.
Maintained thorough documentation of validation processes and outcomes.
Collaborated with cross-functional teams to address and resolve quality concerns.

• Educate undergraduate pharmacy students alongside managing institute's training and placement functions.