1. Rengaraj Narayanaswamy
Mobile: +919952849911 ~ E-Mail: ranga_bio2006@yahoo.co.in
Aspiring for assignments in Project & Process Design / Quality Assurance & Validation / Engineering
Consultancy with a reputed pharmaceutical organisation preferably in Pharmaceuticals,
Biopharmaceuticals, Clinical Research, Life Sciences industries.
Precis
B.Tech. (Industrial Biotechnology) professional with 7.8 years of experience in Validation, Commissioning
of Equipment and Quality assurance activities in Biopharmaceuticals and pharmaceuticals industries.
Currently associated with Mylan Laboratories limited, Hosur as Senior Executive- Validation. Adept at
pharmaceutical projects & process engineering with proven track record in projects and process designing of API
and fill finish facility in the Biopharmaceutical and Pharmaceutical cGMP facility. Acquired comprehensive exposure
in planning and organizing day-to-day research & development activities and executing tasks on a timely basis.
Possessing knowledge of QA aspects and GMP as per different regulatory bodies. A professional with a proactive
attitude, capable of thinking in & out of the box. An energetic, self-motivated team player with hands on
experience in requirements gathering, examination, evaluation and customization.
Career Contour
Feb 2015 to till date
Mylan Laboratories Limited, Bangalore, as Senior Executive- Corporate Validation Group
Key Deliverables
Validation Activities
 Preparations of Validation Master Plan (VMP), Site Master file (SMF), URS (User Requirement Specifications),
Design Qualification (DQ), Commissioning Test Plan (CTP).
 Preparation and execution of Facility Qualification Protocols.
 Preparation and execution of IQ, OQ, PQ for Glove Integrity Testers.
 Preparation and execution of IQ, OQ, PQ protocols for HVAC (Air handling units).
 Preparation and execution of IQ,OQ, PQ protocols for Utilities (Water Pre-treatment Plant, Purified water
system, WFI system, Pure steam system)
 Preparation and execution of IQ,OQ,PQ Protocols for Process equipments (Tunnel, Autoclave, AHUs, Walk in
cold rooms, Stability chambers, Process vessels, Manufacturing tanks, Transfer panel, Bio-Reactors etc.) for
Biopharmaceutical and Pharmaceutical manufacturing facilities
 Preparation and execution of Protocols for LAFs, Pass boxes etc
 Handling QMS activities related to Validation
 Initiation and closure of Planned Deviations and unplanned deviations.
 Conducting investigations for Incidents and deviations.
 Preparation and execution of Computer system Validation protocols (Newtronic Software, Eurotherm Software,
Process Equipments PLC software, Distributed Control System (DCS), Building Management System (BMS).
 Along with user departments initiation of Change controls for facility modifications, equipment modifications,
Utilities modification etc.
 Requalification of Area, Autoclave, tunnel, Stability chambers, cold rooms, LAFs, Pass boxes, temperature
mapping for Controlled areas.
 Identifying areas in lack of quality and taking steps to correct & prevent the occurrence.
Significant Highlights
 Key member in Facility modifications at Mylan Hosur manufacturing facility
 Key member in regulatory inspection (USFDA, MHRA).
 Operation of Anemometer, Aerosol Photometer, Particle counter, data loggers etc. for Area Qualifications and
Equipment Qualifications.
 Involved in SAT, FAT (Site Acceptance test, Factory Acceptance Test) for various equipments.

2. Career Contour
July 2014 to Jan 2015
Amway India, Validation Lead
Key Deliverables
Validation Activities
 Preparation of Validation Master Plan(VMP), Site Master file(SMF), URS, Design Qualification (DQ),
Commissioning Test Plan(CTP)
 Preparation and execution of Computer system validation Protocols Distributed Control Systems (DCS).
 Preparation and execution of IQ, OQ, PQ Protocols for Process equipments (AHUs, Walk in cold rooms, Stability
chambers, Process vessels, Water systems, etc).
 Involving in FAT (Factory Acceptance Test) for various equipments & Commissioning of HVAC systems, Water
systems, Process equipments.
 Scheduling the day to day activities for the projects and to ensure that the project timeline was maintained.
 Commissioning, Preparation and execution of qualification protocols for clean utilities (PW Generation and
storage distribution, WFI Generation and storage distribution, Clean Steam generation, Compressed air
distribution & Nitrogen Distribution) for Neutraceutical manufacturing facility.
 Preparation and execution of Building Management System (BMS).
Significant Highlights
 Key member in Conducting FAT (Factory Acceptance Test), SAT (Site Acceptance Test) for
Equipments, Commissioning of equipments, Preparation of Qualification Protocols (Equipments,
Facility, Process, Cleaning).
Career Contour
March 2011 to July 2014
Hospira Healthcare India Pvt Ltd, Chennai, as Senior Executive –QA Engineer
Key Deliverables
Validation Activities
 Preparation of Validation Master Plan(VMP), Site Master file(SMF),URS,Design Qualification (DQ),
Commissioning Test Plan(CTP)
 Performing Hydraulic Pressure test for Pipelines.
 Involved in facility modifications along with user department.
 Along with engineering department initiation of Change controls for facility modifications, equipment
modifications, Utilities modification etc.
 Preparation and execution of Computer system Validation Protocols (Distributed control systems (DCS), BMS,
Themolab Software,Yokagawa data logger Software)
 Preparation and execution of IQ,OQ,PQ Protocols for Process equipments (Tunnel, Autoclave, AHUs, Walk in
coldrooms,Stability chambers, Process vessels, Water systems, Transfer panel, etc) for Biopharmaceutical and
Pharmaceutical manufacturing facilities
 Preparation and execution of Protocols for LAFs, Pass boxes etc
 Requalification of Area, Autoclave , tunnel, Stability chambers, cold rooms, LAFs, Pass boxes
 Involved in FAT (Factory Acceptance Test) & Commissioning of HVAC systems, Process equipments for
Pharmaceuticals manufacturing facilities.
 Scheduled the project and performed monthly audits and ensured that the project timeline was maintained.
 Preparation and Execution of Building Management System (BMS) protocols.
 Commissioning, Preparation and execution of qualification protocols for clean utilities (PW Generation and
storage distribution, WFI Generation and storage distribution, Clean Steam generation, Compressed air
distribution & Nitrogen Distribution) for Pharmaceutical and Bio Pharmaceutical Facilities.
 Commissioning, preparation and execution of qualification of Process equipments( AHUs, Laminar air flow unit
(LAFs), pass boxes, Chillers, Hot water systems, Chilled water systems)
 Conducting internal audits & training programs.

3.  Identifying areas in lack of quality and taking steps to correct & prevent the occurrence.
Significant Highlights
 Successfully faced and complied the audits for USFDA, MHRA, ANVISA, GCC, and Various Customer audits
(North Star, GSK (GlaxoSmithKline), Perrigo Israel).
 Key member in Project Completion of Ertapenem manufacturing facility.
 Area Qualification (Air velocity, Filter Integrity Testing, Particle Counting, recovery test, etc) Autoclave
qualification, Transfer Panel, Tunnel qualification, Vessel Qualification, Utilities Qualification.
 Involved in SAT, FAT (Site Acceptance test, Factory Acceptance Test) for various equipments.
Career Contour
Jul’07-mar’11
Reliance Life Sciences Pvt. Ltd., Navi Mumbai as Quality Assurance and Validation Executive
Key Deliverables
Process Enhancements
 Preparation and Execution of Installation, Operation and Performance qualification protocols for various process
equipments (Autoclave, Glassware washers, transfer panel, tank vessels, cold rooms, Tunnel, Lyophilizer
temperature Mapping, LAFS, Pass boxes, Chillers, etc).
 Validating clean utilities (PW Generation and Storage distribution, WFI Generation, storage & distribution, Clean
Steam generation, Compressed air distribution, Nitrogen distribution) for Pharmaceutical and Bio
Pharmaceutical Facilities.
 Conducting Process simulation Trial (Media fill).
 Creating Standard Operating Procedure (SOP) for Aerosol photometer, particle counter, Velometer, Data logger
(Yokogawa, Eurotherm), etc & providing training for the same.
 Planning and executing the process validation and cleaning validation related activities for Pharmaceutical &
Biopharmaceutical Products.
 Preparation & execution of cold chain validation protocols.
 Handling the validation related documentation of blood products & recombinant therapeutic protein products.
 Preparation and Execution of Qualification Protocols for HVAC Air handling Units (AHU) systems in
BioPharmaceutical & Pharmaceutical facilities.
 Preparations and Execution of Computer system validation (DCS).
Significant Highlights
 Successfully faced and complied the FDA audits for Irish Medicine Board (IMB), Indian FDA, WHO and
ANVISA and Customer audits (Lupin, RPG life Sciences).
 Successfully assisted in the commissioning activities of Chromatography, vial washing machines, Dry heat
sterilizers and Filling machine, Air handling units (AHUs).
 Conducted validation of various process equipments such as Bioreactors, Autoclaves, Process vessels, Dry Heat
Sterilizers, Vial and Prefilled Syringes Filling Machine, Vial Washing Machine, Transfer Panel, Pass Boxes,
Dispensing Booths and Laminar Air Flow.
 Area Qualification (Air velocity, Filter Integrity Testing, Particle Counting ,etc)
 Involved in SAT, FAT (Site Acceptance test, Factory Acceptance Test) for various equipments.
Trainings Attended
 Clean Room behaviours
 Training Programs in Dry heat & moist heat sterilization.
Certification Course
 Advance Diploma in Biopharmaceuticals Manufacturing at Reliance Institute of Life Sciences.
Project Undertaken

4.  Qualification of Biopharmaceutical Facility.
Seminar / Presentation Attended
 Seminar on “Technical aspects in a Pharma, Biopharma Facility & Personality Development”.
 Delivered presentation on “Importance of qualification of Biopharmaceutical Facility”
B.Tech. (Industrial Biotechnology) in 2007
(P.S.R Engineering College under Anna University, Chennai) with 68%.
IT Skills: Comprehensive exposure to MS Word, MS Excel, PowerPoint and Internet Applications.
Extramural Engagements
 Distinction of representing the college department for AICTE, Delhi.
 Gained exposure in technical report writing and presentation techniques in small group seminar presentations.
Personal Dossier
Date of Birth : 26 Nov 1985.
Present Address : C-11, SIPCOT Housing colony, Dharga, Hosur-635109
Permanent Address : 1/67, E.Muthulingapuram, Naduvapatti (P.O), Sattur (tk)-626203
Virudhunagar district, TamilNadu, India.
Linguistic Abilities : English, Hindi, Tamil & Telugu.