Kiran Kumar

Overall 6.2 years of experience in pharmaceutical formulations and API’s manufacturing sector with expertise in various phases of QA activities.

QA Officer - MATRIX (Mylan Laboratories Ltd.)

(2022-09)

• Preparation and review of Process Validation (PPQP) Protocol and report.
• Preparation of annual product quality reviews reports (APR’s) with using Minitab.
• Review and monitoring of equipment qualifications (DQ,IQ,OQ and Performance Qualification)
• Handling of Approval and Closing major and minor of Change controls.
• Managed Deviation Investigations, conducted root cause analysis, and supported CAPA (Corrective and Preventive Actions) to ensure product quality and compliance.
• Handled and investigated Out of Specification (OOS) results in compliance with GMP and regulatory requirements.
• Review of Analytical Test Reports (ATR’s).
• Review of batch manufacturing records and packing records for peptide molecules, generics and vitamins
• Handling of Product change over clearance (PCO) for Equipment and Area clearance.
• Monitoring of stability studies as per the stability protocols of the respective products according to their regulatory requirements.
• Responsible to arrange audit documents as per audit agenda for various regulatory and customer audits (FAD, WHO,ANVIS,MHRA & TGA)
• Handling regular activities using with software’s. Like SAP, , Track wise, Veeva, Minitab, D2(Documentum for life sciences), Docuzen, and caliber LIMS,

QA Team member - Piramal Pharma Ltd.

(2020-08 - 2022-09)

M.Pharmacy - PIPER College, Warangal (2020)

B.Pharmacy - PIPER College, Warangal (2018)

Intermediate (Bi.P.C) - APSEB Govt. college, Palvancha (2014)

SSC - ZPH School, Palvancha (2012)