Ashish S.

About Ashish S.

A Dynamic Career in Pharmaceutical industry having thorough knowledge of USFDA, MHRA, MDR (EU) etc. Regulatory norms with a vision to give more than the target output under complete compliance with quick problem solving skill, focused to increase the productivity & revenue and to help the firm by indulging into project managements. Strong professional with B.Pharm and MBA from Manipal University Jaipur.Key Skills Or Expertise:A. QMS and Compliance:• Performing and reviewing investigations.• Deviation• Handling of Market Complaint (MDI, DPI, Nasal, Transdermal, Pre-filled syringe for Ophthalmic, Osteoarthritis and Dermal, Medical Devices).• OOS / OOT (Confirmed / Not Confirmed) or (Valid / Invalid).• Quality Risk Management (Qualitative / Quantitative) with thorough knowledge of FMEA and FMECA.• Audit Management. • Handling / Identification of non-conformity in process, document, analysis, procedure etc.• Skilled in performing vendor / contract manufacturer audit at site.• Aware about various investigation tools such as 6M, 5 Why, Brainstorming, FTA and Genchi-Genbutsu.• Handling of Oversights.• Root Cause Analysis.• Implementation of effective immediate action (containment) to prevent any further impact on SISPQ of product, process etc.• Imposing effective CAPA / Global CAPA to prevent recurrence of any reported event/incident.• Component Criticality Assessment after installation/modification of a equipment.• Preparation of URS / UTM.• Performing Initial Risk Assessment.• Audit Trail review of equipment and designing required audit trail report as per 21 CFR. • Preparation, updation and periodic review of SOP.B. Equipment’s Handled:#TransdermalManufacturing • Manufacturing Tank 250L• Ross Multi Mixer• Premix Tank• Liquid Transfer PumpCoating• Coating Drying and Lamination Machine• Tooth Gear Pump• Intermediate Tank• Patch Cutting MachineSlitting• Slitting MachineConverting• Converting and pouching machine (Harro Hofliger)• Converting and pouching machine (Delta)Leak Test • Package Tester#MDI Packaging• Checkweigher (Anritsu, Technofour)• Weighing Balance (Metter Toledo, Sartorius)• Spray Testing Machine (Lactest and Lactest-4)• Sticker Labelling Machine (CVC, Marchesini)• Canister and Actuator Assembling Machine (CAM)• Cartoning Machine (IMA-PG)• CAC (CAM)• PST (Jekson)• Bundling Machine, Stretch Banding Machine• Autofocus Collation Machine (ACG, Jekson)• Shipper Serialisation (ACG)C) Software’s HandledTrackWiseCaliber QAMSSABA, Zytims (LMS)Documentum, QA-EDMS, DMS (EDMS)Caliber LIMSSAP

Experience

1. Senior Executive Qms & Compliance

   Cipla

   Oct 2024 — Present · Indore, IN

Education

• Mandsaur University

  Bachelor of Pharmacy - BPharm

  2017 — 2021

• The Aditya Birla Public School

  High School, Science

  2005 — 2017

• Manipal University Jaipur

  Master of Business Administration - MBA, Operations Management and Supervision