Yogesh Shimpi

Quality Control professional with 18+ years of experience in pharmaceutical analysis across API and formulation domains, supporting regulated markets including US, EU, and ROW. Currently working with Piramal Pharma Limited, leading Analytical Method Validation for complex peptide molecules and driving compliance excellence with right-first-time execution.

I specialize in method validation, regulatory compliance, and investigation systems, with strong exposure to USFDA audits, CDMO projects, and lifecycle management of analytical methods.

Delivered projects within timelines through effective risk management and stakeholder coordination

Trained teams on Data Integrity (ALCOA+), SOP compliance, and analytical troubleshooting

Profile at Piramal Pharma Ltd (Quality control - Deputy manager From Jan 2022)

Location: Navi Mumbai Designation: Deputy manager (Analytical method validation)

⮚ Looking after the validation for complex peptide molecule.

⮚ Preparation of investigation report for QMS documents. Resolving the query and preparation of reports to mitigate and justify the queries.

⮚ Review of the protocols/reports for the Validation/Transfer for US and UK regions

⮚ Reporting of the progress report, risk and mitigation plan of the project to the stakeholder to meet desire timeline. Project of CI to reduce operational cost.

⮚ Trainings to scientists on laboratory compliance such as laboratory investigation, Implementation of SOP’s, ALCOA+, Data integrity and procedure and analytical trouble shooting.

Profile at Perrigo Laboratories Pvt Ltd. (From Jul 2015 to Dec 2021)

Location: Ambernath, Thane Designation: Assistant scientist (Analytical method Development and validation)

⮚ Looking after the Analytical method development of the OTC products/ANDA products marketed for the US markets.

⮚ Preparation of the protocols/reports for the method Validation/Transfer for US and UK regions

⮚ Analysis of as per validation protocol, stability schedule programme.

⮚ Reporting of the progress report, risk and mitigation plan of the project to the stakeholder to meet desire timeline.

Profile at Analytical Solution Pvt. Ltd. ( From Jun 2014 to Jun 2015)

Location: Navi Mumbai Designation: ADL Executive (Analytical method Development and validation)

⮚ Analytical method development and validations of API and formulation.

⮚ Calibration of the instruments.

⮚ Monitoring the day to day activities of the team members and provide timely feedback.

⮚ An effective communicator with excellent team leadership skills (through conference calls) with multiple companies.

Profile at Athena DDS Pvt. Ltd. (From Jun 2012 to May 2014)

Location: Ambernath, Thane Designation: ADL Officer (Analytical method Development and validation)

⮚ Analysis of Raw material, in- process and finish product samples of various API and their Formulations.

⮚ Conducting Technology Transfer & Demonstration of Analytical Techniques to Quality Control Departments of subsidiaries units of Organization with Interference studies during product Development.

Profile at Cipla Pvt. Ltd. (From Apr 2010 to May 2012)

Location: Mumbai Designation: ADL Officer (Third party projects)

⮚ Performing the routine analysis of the API’s for the Assay and Impurity analysis by HPLC/Gas Chromatography for Third party Projects.

⮚ Expertise on working all types of formulation dosage forms like Tablets, Capsules, Syrup, Ointments and Injections in developing methods, also carrying out stability studies.

⮚ Performing the Daily calibration of Analytical Balances/Karl fisher instruments and HPLC’s.

Profile at Medibios Laboratories Pvt. Ltd. (From May 2008 to Mar 2010)

Location: Bhoisar, Thane Designation: Quality control chemist (API and finish product analysis)

⮚ Performing the routine analysis of the API’s and Generic products analysis by HPLC/Gas Chromatography and wet analysis for In-process/intermediate and the Finished products.

⮚ Sampling of API and Excipients.

⮚ Master of Science (M.Sc.) Organic Chemistry - (2006-2008): Smt. G.G. Khadse College, North Maharashtra University, Jalgaon.

⮚ Certified course: Essential of Biomoleculs, amino acid and peptide from IIT Guvahati.