Summary
Overview
Work History
Education
Skills
Languages
Timeline
Generic

ANANTHU MOHAN

ALAPPUZHA

Summary

Senior Executive in Quality Assurance and Engineering with significant experience at Microlabs Ltd, focusing on equipment and software validation. Demonstrated proficiency in regulatory compliance, including CSV and equipment qualification. Achievements include enhancing operational efficiency and producing high-quality technical documentation. Expertise in employee training and developing qualification protocols, ensuring excellence in quality control and customer support.

Overview

8
8
years of professional experience

Work History

SR EXECUTIVE IN QUALIFICATION AND VALIDATION

MICROLABS LTD
BANGALORE
07.2021 - Current
  • Responsible for the qualification and validation of software, equipment, and instruments.
  • Excellent knowledge in the operation and validation of utility equipment, such as HVAC systems, water systems, and compressed air systems..
  • Excellent experience in the validation of computer applications such as ICDAS 3.1 for stability chambers, SCADA systems, WinCC applications for purified water systems, Indusoft Web Studio, Marlin MX3.0 for tablet inspection systems, BMS systems, EMS systems, TwinCAT applications, stability control system software for BOD incubators, NovaLog applications for ERH meters, Easydirect applications for moisture balance, and all 21 CFR Part 11 compliance applications.
  • Expertise in conducting risk assessment, 21 CFR PART 11 assessment, security assessment, and documenting as per GAMP 5 guidelines. Heavy emphasis on CSV, instrument/equipment validation, software quality assurance, with profound knowledge of FDA regulations documenting validation protocols (IQ, OQ, and PQ).
  • Expertise in documenting User Requirement Specification (URS), Design Specification (DS), Configuration Specification (CS), Vendor Assessment, GxP assessment, Design Qualification, ER-ES readiness assessment, Functional Risk Assessment, Qualification documents, Requirement Traceability Matrix, Data Integrity Checklist Verification Report, and Final ER-ES Assessment.
  • Expertise in documenting design reviews and technical writing.
  • Excellent understanding of the Software Development Life Cycle. (SDLC)
  • Hands-on experience in manual testing of various applications, and developed test plans and deliverables.
  • Responsible for equipment requalification, PLC validation, and requalification.
  • Performing seasonal temperature mapping of storage areas and QC equipment.
  • Performing area qualification, AHU qualification, HVAC qualification, compressed air system qualification, and purified water system qualification.
  • Hands-on experience in the operation of purified water systems and HVAC systems.
  • Hands-on experience in the calibration of critical components of all process equipment and utility equipment.
  • Excellent understanding of calibration certificates and traceability certificates provided by the vendor.
  • Expertise in handling market complaints, QMS activities like change control initiation, and preparation of relevant action plans in the TrackWise application.
  • Worked with many automation and process systems like PLC, HMI, and custom software systems for unit operations like blending, compression, drying, coating, and packing.
  • Expertise in conducting training sessions of different qualified software and equipment.
  • Facilitated communication between different departments resulting in improved collaboration among teams.
  • Provided leadership, insight and mentoring to newly hired employees to supply knowledge of various company programs.

Field Engineer (Project and Services)

ION EXHANGE INDIA LTD
BANGALORE
08.2017 - 04.2021
  • Responsible for the erection and commissioning of the purified water system with SCADA software, demineralization plant, RO plant, UF plant, MGF, and ACF.
  • Responsible for the calibration of critical instruments, like flow meters, pH meters, conductivity meters, ORP meters, pressure gauges, Magnehelic gauges, hour meters, temperature sensors, UV meters and sensors, pressure switches, level switches, RPM meters, ammeters, voltmeters, and heaters.
  • Preparation and execution of qualification documents for customers.
  • Handled multiple projects in pharma companies like MEDRICH, CIPLA, MICROLABS, NATURAL REMEDIES, MYLAN, GLOBAL CALCIUM, etc.
  • Provided technical support for customers on site or remotely via phone or email.
  • Responded quickly to emergency calls from customers regarding technical issues.
  • Installed, configured and commissioned new customer equipment according to specifications.

Education

BTECH - ELECTRONICS AND COMMUNICATION ENGINEERING

COLLEGE OF ENGINEERING ADOOR
ADOOR
04-2015

CLASS 12 TH - Science

S N TRUST HSS
ALAPPUZHA
03-2011

TENTH - Science

K E CARMEL CENTRAL SCHOOL
ALAPPUZHA
05-2009

Skills

  • Computer system validation (CSV)
  • PLC validation
  • Qualification protocol preparation
  • Risk assessment
  • Audit trail review
  • User management review of software
  • Quality control, production, and packing equipment qualification
  • Regulatory compliance
  • Document management
  • Equipment qualification
  • Temperature mapping
  • AHU qualification
  • Area qualification
  • calibration
  • Technical writing
  • Employee training
  • Data integrity
  • Test planning
  • Customer support

Languages

Malayalam
First Language
English
Upper Intermediate (B2)
B2
Tamil
Intermediate (B1)
B1
Hindi
Intermediate (B1)
B1
Kannada
Intermediate (B1)
B1

Timeline

SR EXECUTIVE IN QUALIFICATION AND VALIDATION

MICROLABS LTD
07.2021 - Current

Field Engineer (Project and Services)

ION EXHANGE INDIA LTD
08.2017 - 04.2021

BTECH - ELECTRONICS AND COMMUNICATION ENGINEERING

COLLEGE OF ENGINEERING ADOOR

CLASS 12 TH - Science

S N TRUST HSS

TENTH - Science

K E CARMEL CENTRAL SCHOOL
ANANTHU MOHAN