R PAZHANI MURUGAN
Bangalore
Summary
Accomplished Senior Executive Microbiologist with extensive experience in quality management systems, equipment qualification, and validation processes across leading pharmaceutical organizations. Proficient in cGMP applications, Labware LIMS V 7.0, Trackwise V10.6.0, MS SQL Developer, Lonza MODA, SAP, and ValGenesis V4.1.
Steered Audit readiness and regulatory authorities inspections (USFDA, MHRA, Health Canada, ANVISA, EU-GMP, CDSCO, and WHO).
Proficient in handling deviations, root cause analysis, change controls (PC and TC), corrective and preventive actions, CAPA effectiveness checks for post-implementations, and training coordination to drive operational excellence.
Overview
11
11
years of professional experience
Work History
Senior Executive Microbiologist
Steriscience Specialties Private Limited
Bangalore
08.2022 - Current
- QMS - Handling of Deviations, RCI, Failure investigation, CAPA, Change control, SOP revisions, OOL, and QRM evaluation.
- Equipment qualification URS, IQ, OQ, and PQ.
- Computerized system validation (URS, OQ,PQ) execution and script review in ValGenesis.
- Labware LIMS V 7.0- master data management, equipment ID creation, product configuration, analysis validation, migration to production server.
- Analytical and EM Reviewer.
- Department Training coordinator.
- Sterility and BET method validation-protocol preparation, execution and approval.
- Miscellaneous validation- protocol preparation, execution and approval.
- Media and Materials purchase requisition creation in SAP.
Senior Executive Microbiologist
Biocon Biologics Limited
Bangalore
08.2019 - 07.2022
- QMS activity- Handling of Lab incidents.
- Initiation and closure of deviation, OOS, OOAC and OOAL.
- BET and MLT testing for Inprocess samples.
- Water trend preparation.
- Suitability testing-Media, Bioball and Biological Indicators.
Executive Microbiologist
Pfizer Health care
Chennai
08.2017 - 07.2019
- Sterility and BET testing for inprocess, finished product and stability samples.
- Environmental Monitoring.
- EM Trend preparation.
Associate Microbiologist
Mylan SFF
Bangalore
08.2015 - 08.2017
- Microbiological Monitoring of water system.
- Water Trend preparation.
- Growth promotion test.
- Biological indicator suitability and recovery.
- Microbial Limit Test for raw material, packing material, In-process, finished products as per analytical methods and documentation.
- Disinfectant efficacy test.
Quality control officer
Green Chem
Bangalore
04.2014 - 07.2015
- Method development of GC-MS for raw material.
Project fellow
Periyar University
Salem
01.2010 - 04.2014
- Drug discovery for Multidrug resistant pathogens.
Education
M.Sc. - Microbiology
Sri Sankara Arts & Science College
Kanchipuram01.2009
B.Sc. - Microbiology
Sri Sankara Arts & Science College
Kanchipuram01.2007
Skills
- Quality management system/internal audit/training management
- QMS (Change control,Event/Deviation, CAPA
- Implementation of SOPs, Revision and Training & Development
- Implementation of SOPs, Revision and Training & Development
- Quality Risk Management (FMEA)
- Commissioning and Qualification of Equipment in Biopharmaceutical
- Digitalization project for Labware LIMS 70, Vitek-2, MODA and SCADA
- Bioinstrumentation techniques-GC MS, HPLC and AAS
Personal Details
Date of birth:14th March, 1987
Languages Known: English, Tamil and Kannada
Permanent Address: 14A/ 2A/1,Poonga Nagar, 3rd street,
Vallioor, Tirunelveli (Dt), Tamilnadu, India.
Pin code: 627117
Timeline
Senior Executive Microbiologist
Steriscience Specialties Private Limited
08.2022 - Current
Senior Executive Microbiologist
Biocon Biologics Limited
08.2019 - 07.2022
Executive Microbiologist
Pfizer Health care
08.2017 - 07.2019
Associate Microbiologist
Mylan SFF
08.2015 - 08.2017
Quality control officer
Green Chem
04.2014 - 07.2015
Project fellow
Periyar University
01.2010 - 04.2014
M.Sc. - Microbiology
Sri Sankara Arts & Science College
B.Sc. - Microbiology
Sri Sankara Arts & Science College
Similar Profiles
S MohankumarS Mohankumar
Executive at OneSource Specialty Pharma LimitedExecutive at OneSource Specialty Pharma Limited
Thulasidhevan SThulasidhevan S
Senior Executive at Steriscience private LimitedSenior Executive at Steriscience private Limited
Justin Raj AJustin Raj A
Executive - Human Resource at Steriscience Specialties Pvt LtdExecutive - Human Resource at Steriscience Specialties Pvt Ltd
Pooja MukundanPooja Mukundan
Associate - RMC Governance Officer at J P Morgan Chase & CoAssociate - RMC Governance Officer at J P Morgan Chase & Co
Raghu Vamsi MRaghu Vamsi M
Associate Manager- Finance at Reverie Language Technologies LimitedAssociate Manager- Finance at Reverie Language Technologies Limited