Experience

Pharmaceutical Marketing

• United Kingdom
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Manager

  • Mar 2022 - Present

  1. Quality by Design: a. Identification of CQA's b. Process Parameters & Source of Variability. c. Perform Risk Assessment as per ICH Q9- Identification, Analysis, Evaluation, Control, Reduction, Acceptance & Risk Review. d. Life Cycle Management with Continuous Improvements. 2. Process Validation/ Qualification/ Continued Process Verification 3. Hands on Experience in a. Change Control Management b. Deviations c. Complaints and Investigations d. NCR's: Minimization, Address and Elimination of NCR's e. Corrective & Preventive Actions (CAPA's): Timely Completion, Address with Application's and Techniques. f. GAP Analysis. g. Audit Trail 4. Implementation of Quality System as per the Regulatory Requirements such as EU GMP, Schedule M, WHO TRS, PICS, USFDA & ICH Q10 guidelines. 5. Product Quality Reviews 6. Six Sigma: Process Capabilities & Statistics. 7. Training & Development: Identification of Training Need, on job Training, Certification etc. 8. Regulatory Inspection/ FDA/CDSCO/WHO GMP/MOH Russia/Ukraine/EU GMP: Regulatory Audit finding drafting finalization of query with Responses. 9. Review of Analytical Method Validation ICH Q2, Stability Testing ICH Q1, Impurities ICH Q3 10. Good Manufacturing Practices Implementation & Compliances at Various Manufacturing Site & Dosage Forms. 11. Vendor Qualification & Approvals 12. Loan License for Export Products: To ensure quality of Products as per the regulatory quality standards. 13. Cleaning Validation: Multi Product sharing Facility Evaluation & Finalization of Cleaning Methods and Matrix as per the Guidelines. Conventional to Pharmacological-Toxicological Evaluation. 14. Pharmacology and Pharmaceutical Chemistry: Hands on Experience in a. Biopharmaceuticals: Pharmacokinetics & Pharmacodynamics studies. b. INVIVO, INVITRO Studies. c. Spectroscopic & Chromatographic Techniques: NMR, Mass, IR, HPLC with Current Software d. Computerized System Validation (CSV), Data Integrity, SAP, ERP, LIMS & Track wise etc. Show less



Self Employed

• United States
• 700 & Above Employee

• Academic - Freelance

  • Feb 2022 - Present



Shreya Life Sciences Pvt. Ltd.

• India
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Manager

  • Mar 2021 - Present

• Assistant Manager

  • 2018 - Present

• Sr. Executive

  • Apr 2016 - Present

• Executive

  • Sep 2011 - Present