Summary
Overview
Work History
Education
Skills
Certification
Accomplishments
Regulatoryauditsfaced
Personal Information
Languages
Disclaimer
Timeline
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Arun Prasath

Arun Prasath

Business Solution Leader
Hosur

Summary

A highly motivated and results-oriented professional with over 13 years of experience in Analytical Development & Quality Control, and 3 years in Software Design and Development. Seeking a leadership role in an organization that values initiative, efficiency, and continuous professional growth. Hard-working Supervisor with exceptional experience leading teams, delivering results and exceeding expectations. Creative and motivated leader adept at utilizing exceptional design and planning strengths to accomplish complex projects. Skilled in teaching new concepts and best practice strategies.

Overview

17
17
years of professional experience
3
3
Certifications

Work History

Solution Leader (Manager – Business Solution)

Brane Enterprises Private Limited
7 2021 - Current
  • Led digital transformation initiatives for Quality Management Systems (QMS) and Laboratory Information Management Systems (LIMS).
  • Designed, developed, and deployed solutions for Construction and Car platforms, achieving production go-live within two weeks
  • Reviewed solution developments across QMS, LIMS, Construction, and Digicars solutions to ensure alignment with client requirements.
  • Developed and maintained validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), ensuring compliance with regulatory standards (FDA GMP).
  • Led cross-functional teams to achieve company-wide goals, fostering a culture of collaboration and innovation.
  • Overcame challenging deadlines and resource limitations by reallocating personnel and focusing on priority tasks.
  • Led team by answering complex customer questions and mentoring personnel one-on-one.
  • Identified team weak points and implemented corrective actions to resolve concerns.
  • Evaluated customer needs and feedback to drive product and service improvements.
  • Facilitated training sessions for internal staff, improving adherence to validated processes.

Assistant Manager (Documentation)

Caplin Steriles Limited
03.2019 - 06.2021
  • Managed the preparation and approval of specifications in QMS Trackwise for various materials, ensuring timely delivery of documents.
  • Coordinated with SMEs for change control records (CCR) completion and compliance with the latest pharmacopoeial editions.
  • Played a key role in harmonizing Standard Operating Procedures (SOPs) and documentation processes, ensuring they met GDP requirements.

Team Leader (Documentation)

Apotex Research Pvt. Ltd.
07.2009 - 03.2019
  • Led the Quality Control documentation team, facilitating seamless audits by agencies such as USFDA, WHO, and Health Canada.
  • Oversaw the configuration and management of LabWare LIMS, ensuring smooth operation and compliance with regulatory standards.
  • Created new CCRs in QMS for material master and product code inclusion, significantly improving documentation accuracy and efficiency.
  • Set performance expectations for the team, monitoring progress towards goals and providing constructive feedback as needed.
  • Collaborated with other department leaders to establish shared goals and ensure alignment across teams.
  • Maintained an inclusive and diverse team culture, promoting respect and understanding among all members.
  • Streamlined workflows for increased efficiency, reducing turnaround times for critical tasks.

Documentation Specialist

Microlabs Ltd.
01.2008 - 06.2009
  • Handled Quality Control documentation, ensuring timely completion of all specifications, protocols, and summary reports.
  • Played an integral role in the harmonization of test methods and specifications, reducing inconsistencies across departments.
  • Collaborated with quality assurance team to comply with regulatory requirements.

Education

MBA - QMS & IT

National Institute of Business Management
Chennai, India
04.2001 -

BBA - Business Administration

University of Madras
Chennai, India
04.2001 -

Diploma in Electrical & Electronic Engineering -

Swamy Abedhanandha Polytechnic College
Tiruvannamalai, India
04.2001 -

Skills

LabWare 7 LIMS Application Support and Administration

Certification

Certified Pharmaceutical GMP Auditor (CPGA) – ISQSH

Accomplishments

  • Reduced the workload for secondary packing material specifications from 10 days to 3 days by streamlining processes.
  • Improved lab efficiency by consolidating in-process, semi-finished, finished product, and stability data testing.

Regulatoryauditsfaced

  • USFDA (United States Food and Drug Administration)
  • WHO (World Health Organization)
  • MHRA (Medicines and Healthcare products Regulatory Agency)
  • MCC (Medicines Control Council)
  • TGA (Therapeutic Goods Administration)
  • GCC (Gulf Cooperation Council)
  • Turkey Ministry of Health
  • Health Canada

Personal Information

  • Date of Birth: 06/05/86
  • Nationality: Indian
  • Marital Status: Married

Languages

Tamil, English, Telugu, Kannada

Disclaimer

I hereby confirm that the information given above is true to the best of my knowledge.

Timeline

Assistant Manager (Documentation)

Caplin Steriles Limited
03.2019 - 06.2021

Team Leader (Documentation)

Apotex Research Pvt. Ltd.
07.2009 - 03.2019

Documentation Specialist

Microlabs Ltd.
01.2008 - 06.2009

MBA - QMS & IT

National Institute of Business Management
04.2001 -

BBA - Business Administration

University of Madras
04.2001 -

Diploma in Electrical & Electronic Engineering -

Swamy Abedhanandha Polytechnic College
04.2001 -

Solution Leader (Manager – Business Solution)

Brane Enterprises Private Limited
7 2021 - Current

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