Ganesh Achar Email & Phone Number

Berlin, Germany

Embarking on a cutting-edge GMP Oligonucleotide greenfield project

India

Presently working as Senior Exective in Corporate Quality Assurance , Review of audit trails, CSV, gap assessment, SAP validation, are the major area of experience. Setting new GMP pharmaceutical which meets the regulatory requirements is the major milestone in the career. Worked with the majority of Distributed Control system, PLC systems, SCADA and EMS,BMS,Server qualification.reviewing and approving of OQ and PQ test scripts, backup and restoration verification.reviewing and approving of yearly backup schedule, restoration as per the planner. Involved in the vendor qualification, vendor audit, quality agreement activities and contract testing laboratory audits.Having the experience in the warehouse quality management.

Bengaluru, Karnataka, India

- Currently handling Greenfield Project of manufacturing units(Intermediates/API’s/Biologics).- Leading the qualification team and participation of daily project meetings and handling day to day targets.- Preparation of Weekly, Fortnightly and Monthly department reports/slides. - In the different phase of equipment qualification (ISPE C&Q Vol 5) perform the below activities:- Ensuring GXP requirements while performing Equipment commissioning and Qualification activity in facility.- Draft and review of SOPS related to commissioning, Qualification & validation.- To manage change control, deviations, CAPA, Risk assessments related to facilities and equipment.- Conducting Vendors/Service provider audits.- Review of facility related drawings.- Responsible for Scheduling, planning and execution of qualification/requalification (equipment, HVAC, Water system, Gases qualification) related to facility.- Prepare, review and execution of qualification/requalification protocols and reports. (URS, DQ, FAT/SAT, IQ, OQ and PQ, Drawings and Facility Layouts)- Execution of Thermal mapping activities for equipment.- Responsible of AHU qualification as per ISO standards.- To provide initial and regular training to team and other department personnel SOPS and protocols related to Validation, qualification/Requalification.- Accountable for overall GxP validation and Compliance of the system in the different phase of GAMP 5 “V” model, involved in the below activities for developing, implementing and maintaining the computerized system.

India

*Executed the validation process for batches of oligonucleotide products to ensure their quality and consistency, *I have extensive hands-on experience in TFF systems, ion exchange purification, and freeze-drying.*Hands on experience in Synthesizer (OP-400).:*Column packing and evolution with Fine Line 70, 100 and 200 and AxiTide 140,*Handled equipment’s like AKTA process, UniFlux 30, OP400, Lyo 10, Filter Integrity Tester (SartoCheck 4 plus), cassette Holder, Cartridge housing, pH and conductivity meter, reactor, Autoclave.*Worked with SCADA, PLC, HMI and DCS.*I have extensive experience in greenfield oligonucleotide projects which involving develop project plans, designing and commissioning production facilities, and ensuring compliance with regulatory requirements*I have extensive knowledge in commissioning and qualification (C&Q) of pharmaceutical manufacturing facilities*Hands-on experience in installation, operational and performance qualification of synthesizer(OP-400), AKTA process, UNIFLUX 30, Cleavage & Deprotection vessel, Sarto Check 4(filter integrity tester), Lyophilizer, WFI operation, OLIGO facility qualification*Trouble shooting, plant stabilization and productivity enhancement for production of existing plant.*Hands on experience Computer System Validation.

Bangalore

Been involved in the cGMP facility qualification,Hands on experience in SS reactor, MSGL reactor, Hastelloy reactor,Work experience in High Potent Active Pharmaceutical Ingredients facilities Handled 20gram batch size to 300kg output. Hands on experience in classification area in clean room.Hands on experience in agitated nutsche filter dryer.Hands on experience in size reduction equipment’s,Hands on experience in Water for Injection(WFI) generation and distribution system-purified water generation and distribution system-process water generation system.Preparation of GDP documents like SOP, EOP, ECC, BMR.Involved in Equipment Qualification. Preparation of IQ, OQ and PQ documents and execution of PQ.Hands on experience in setting up a green Field pharma project Hands on experience in all qualification documents including execution.Hands on experience in commissioning and qualification Audit Exposure (FDA, PMDA and client audits). Hands on experience in facility qualification,Hands on experience in cleanroom equipment’s and operations includes area environment monitoring,Hands om experience in batch planning.Handled validation batches of oligonucleotide products,Hands on experience in TFF systems, ion exchange purification and freeze drying,Hands on experience in Synthesizer (OP-400).Column packing and evolution with Fine Line 70, 100 and 200 and AxiTide 140,Handled equipment’s like AKTA process, UniFlux 30, OP400, Lyo 10, Filter Integrity Tester (SartoCheck 4 plus), cassette Holder, Cartridge housing, pH and conductivity meter, reactor, Autoclave.Worked with SCADA, PLC, HMI and DCS.Handled isolators (HPAPI facility).