Summary
Overview
Work History
Education
Skills
Training
Languages
Timeline
Generic

Prabhakaran Elangovan

Chengalpattu

Summary

Dynamic Quality Control/Assurance professional with a proven track record at HLL Biotech Ltd., adept in document management and strategic decision-making. Excelled in establishing microbiology labs, enhancing quality processes, and leading teams to achieve efficiency. Skilled in MS Office and team building, significantly contributing to regulatory compliance and operational excellence.

Overview

17
17
years of professional experience

Work History

Deputy Manager - Quality Control

HLL Biotech Ltd., Chengalpattu
Chengalpattu
04.2017 - Current
  • Established a microbiology lab in the Greenfield project for sample testing and documentation.
  • Managed daily operations, delegating tasks to team members to optimize productivity and efficiency.
  • Preparation and review of Quality Documents required for lab operations, SOPs, and protocols pertaining to lab operations.
  • Implemented validation of laboratory equipment, various processing systems such as water system, HVAC, and autoclaves.
  • Handling of Quality Management System documents such as Change controls, Deviations and Incidents pertaining to Quality Control department and CAPA.
  • Application of statistical tools in data analysis of test results and preparation of trend charts.
  • Development and Validation of Testing methods such as Bio-burden, Sterility etc. in Raw materials, In-process and Finished products.
  • Prepared detailed reports on departmental challenges and achievements, presenting findings to senior management.
  • Managed implementation of training to department staff.

Overall Career Highlights

Pharmaceutical Quality Control / Quality Assurance
03.2008 - Current
  • Established microbiology labs in the Greenfield projects of 3 pharmaceutical companies.
  • Managed daily operations, delegating tasks to team members to optimize productivity and efficiency.
  • Preparation and review of SOPs and protocols pertaining to lab operations.
  • Managed document issuance, receipt, storage and retrieval during daily operations.
  • Handling of Quality Management System documents, such as Change controls, Deviations, and Incidents.
  • Managed Corrective and Preventive Actions (CAPA) for audit observations.
  • Exposure in document management during Regulatory inspections and other audits.
  • Played a role as an ISO certified internal auditor.
  • Managed License inspections from Regulatory bodies and Customers audits.
  • Participated in the Risk assessment of Medical devices based on ISO 14971:2012.
  • Application of statistical tools in data analysis of test results and preparation of trend charts.
  • Prepared detailed reports on departmental challenges and achievements, presenting findings to senior management.
  • Participation in Procurement Tender process: Identification of required materials for lab operations, Vendor identification, price inquiry and participation in the tender publishing, technical evaluation of vendors and coordination of the purchase with the Procurement team.
  • Engaged in technical interviews along with HR team during recruitment in microbiology department.
  • Preparation of Annual and activity-specific Budgets.
  • Conducted vendor site audits.
  • Monitored inventory levels, placing orders to replenish stock while adhering to budget constraints.
  • Oversaw employee training activities within the QC.

Assistant Manager - Quality Control

HLL Biotech Ltd.
Chengalpattu
04.2016 - 03.2017
  • Assisting Manager - QC in Setting up the Microbiology Laboratory
  • Budget Preparations
  • Identification of required Equipment, Chemicals and Consumables for lab operations and Vendor identification, price inquiry and participation in the tender publishing, technical evaluation of vendors coordination of the purchase with the Procurement team
  • Preparation and review of SOPs and Validation Protocols for Microbiology lab operation
  • Participation in the Pharmaceutical Water system commissioning

Senior Officer - Microbiology

Ocean Health Care Pvt. Ltd.
Chengalpattu
03.2015 - 03.2016
  • Setting up of Microbiology laboratory in Green field project
  • Preparation of SOPs, Validation Protocols related to microbiology laboratory start up and manufacturing area validations
  • Participating in Factory acceptance tests and Vendor audit
  • Preparation of budget for lab start-up and routine operations
  • Execution of Commissioning, Qualification and Validation of Microbiology area and Equipment along with Engineering and QA team
  • Led a team of 3 members in the Microbiology department, allocating routine jobs and monitoring the results
  • Imparting training to the QC Microbiology team
  • Execution of Water, HVAC, Surface and Personnel Qualification/Validation of QC, R&D and Manufacturing areas
  • Handling of Incidents, Deviations and CAPA based on the day to day events and Regulatory audits
  • Engaged in technical recruitment interviews regarding Microbiology with HR team

Senior Officer - Quality Assurance

Eucare Pharmaceuticals Pvt. Ltd.
Chennai
05.2014 - 03.2015
  • Managed the day to day activities of Quality Assurance
  • Preparation and Review of documents such as SOPs, Validation protocols/reports, Qualification protocols/reports
  • Ensuring the In-process quality assurance checks for Medical devices manufacturing
  • Involved in the Document issue, receipt, storage and Retrieval in day to activities and during audits
  • Exposure in document management during Regulatory inspections and other audits
  • Played a role as an internal auditor with certified training on ISO 13485:2012
  • Participated in Vendor Assessment along with Purchase department
  • Managed License inspections from CDSCO and certification audits for ISO 9001, ISO 13485
  • Participated in the Risk assessment of Medical devices based on ISO 14971:2012
  • Audited the Gamma Irradiation facility used for the terminal sterilization of Medical devices

Officer - Microbiology

Fourrts India Pvt. Ltd.
Chennai
08.2010 - 04.2014
  • Setting up of Microbiology Laboratory in Green field Project
  • Preparation of SOPs
  • Area Qualification (Viable count monitoring by settle plate and Air sampler methods) of clean rooms including determination and identification of sampling points in each classified area
  • Qualification, Validation and Routine Monitoring of Water system (Sampling and testing)
  • Executed the Qualification of Clean room equipments like Laminar air flow, Dynamic pass box
  • Temperature mapping in Incubator, Hot air oven, Refrigerator
  • Load pattern validation for Autoclave sterilization
  • Testing of Raw materials, Packing materials, In-process and Finished products for Microbial parameters
  • Preparation of Media, GPT and Maintenance of Microbial cultures
  • Identification of microbial isolates (using Manual API kit from Biomeriuex) from purified water system and Environment and maintenance of isolate library
  • Microbial monitoring of production area surfaces, clean room personnel, drain points and compressed air
  • Preparation of Trend Charts pertaining to Water system and HVAC validation and routine monitoring

Microbiologist-Quality Control/ Quality Assurance

Eucare Pharmaceuticals Pvt. Ltd.
Chennai
03.2008 - 04.2010
  • Sampling of Raw materials, In-process materials and Finished Products for Microbial testing
  • Testing of Routine Water Samples and Microbial Monitoring of Clean rooms and Personnel
  • Microbial Limit testing of Raw materials, In-Process materials
  • Sterility testing of Finished Products
  • Preparation of Microbial media and performing growth promotion testing

Education

Master of Science - Applied Microbiology

Mohammad Sathak College of Arts and Science
Chennai
01.2007

Bachelor of Science - Microbiology

Vels College of Science
Chennai
01.2005

Skills

  • Document Preparation, Review and Management
  • Quality assurance processes
  • Quality control procedures
  • Strategic decision-making
  • Team building
  • MS office Software Proficiency
  • Training program design
  • Data interpretation and reporting
  • Inventory management systems
  • Ability to train

Training

  • Attended training on CGMP: Pharmaceutical Validation, Center for GMP, 2016
  • Training on Risk Management as per ISO 14971:2012, external agency, 2014
  • Internal Auditor Training in line with the ISO 13485:2012 standard, external agency, 2014
  • Attended 2 days training program on USP pharmaceutical water, United States pharmacopoeia, 2013, Hyderabad

Languages

Tamil
First Language
English
Upper Intermediate (B2)
B2
Hindi
Beginner
A1

Timeline

Deputy Manager - Quality Control

HLL Biotech Ltd., Chengalpattu
04.2017 - Current

Assistant Manager - Quality Control

HLL Biotech Ltd.
04.2016 - 03.2017

Senior Officer - Microbiology

Ocean Health Care Pvt. Ltd.
03.2015 - 03.2016

Senior Officer - Quality Assurance

Eucare Pharmaceuticals Pvt. Ltd.
05.2014 - 03.2015

Officer - Microbiology

Fourrts India Pvt. Ltd.
08.2010 - 04.2014

Overall Career Highlights

Pharmaceutical Quality Control / Quality Assurance
03.2008 - Current

Microbiologist-Quality Control/ Quality Assurance

Eucare Pharmaceuticals Pvt. Ltd.
03.2008 - 04.2010

Master of Science - Applied Microbiology

Mohammad Sathak College of Arts and Science

Bachelor of Science - Microbiology

Vels College of Science

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Prabhakaran Elangovan