Summary
Overview
Work History
Education
Skills
Key Qualifications
Languages
Instrumentation
Computing skills
Training Details
Personal Information
HOBBIES
Disclaimer
Timeline
Volunteer

KAMALAKANNAN SUBRAMANI

Salem,TN

Summary

Accomplished QA expert in strategic planning and interpersonal communication. Spearheaded quality assurance projects, leveraging expertise in Watson-LIMS and compliance software, significantly enhancing regulatory adherence. Proven track record in leading teams.

Overview

13
13
years of professional experience

Work History

Asst.Manager (QA)

PAR Biosciences Ltd
04.2014 - 07.2022
  • Preparation & presentation of Quality update, Quality review meeting & Trend analysis.
  • Expertise in processing project data in Watson-LIMS (by Thermo Fisher scientific) and ensure assurance.
  • Review & Approve CSV documents as per URS, 21 CFR Part-11 & EU-GMP Annex-11.
  • Review & Approve Instruments IQ, OQ & PQ Documents as per URS & ensure compliance.
  • Expertise in LC-MS/MS data processing software for ensuring compliance for more than 120 projects as per applicable guidelines.
  • Handled Integration manager software (Interface software).
  • Handled e-QMS software, Track-wise digital - to handle Event, Change control, CAPA and System audits.
  • Handled Master control- for SOP preparation, review and its revisions.
  • Handled Compliance wire software for Learning management system of Employees.
  • Conducted audit for various documents like Plan, protocol, project reports.
  • Managing team for regulatory Inspections like USFDA & EMA for ongoing basis .
  • Involved in implementation & review of various software i.e. LIMS, Sample manager LIMS, etc.
  • Developed and implemented comprehensive quality assurance plans to monitor product quality and adherence to regulatory standards.

Sr.Executive (QC-Bioanalytical)

Syngene International Ltd
07.2010 - 04.2014
  • To be responsible for manage Quality control & Monitoring GLP system at Bio-analytical Lab.
  • To conduct In-process & retrospective audit for various projects like Bio-analytical Method development, Validation, Study sample analysis through LC-MS/MS and ensure compliance to relevant STP, protocol & SOPs.
  • To review & finalize various documents like SOP, IOP, Bio Analytical reports, COA's, MSDS etc.
  • Involved in event/CAPA review
  • Ensure System readiness for regulatory Inspection & Sponsor/ Client audits.

QA Chemist

Bafna Pharmaceuticals Ltd
05.2009 - 07.2010
  • To be responsible for Line clearance & In-process Quality Assurance verification during Production activity.
  • Involved in sampling, In-process checks for production & validation batches.
  • To review BMR, Standard operating procedures, analytical specifications etc.
  • Involved in readiness of regulatory audits and assisting inspection process.

Education

M.Pharm - Pharmaceutical Analysis

Anna University
Tiruchirappalli
06.2009

B.Pharm -

Cherraan's College of Pharmacy
Coimbatore
02.2006

Skills

    • Planning & decision making
    • Department management
    • Interpersonal skills
    • Strategic thinking
      • Communication
      • Conceptual skills
      • Quality assurance expertise

Key Qualifications

  • About 6 years of experience in assuring CSV of software Qualification and good knowledge in GAMP5 requirements.
  • More than 6 years of experience in implementation of Watson-LIMS & Sample manager- LIMS as a compliance auditor.
  • 6 years of experience in handling eQMS (Electronic Quality Management Systems) i.e. TWD & Master control etc.
  • More than 10 years of experience in Regulatory compliance monitoring as per USFDA, EMA, ICH-GLP & GCP.

Languages

Tamil
Bilingual or Proficient (C2)
English
Advanced (C1)
Kannada
Beginner (A1)

Instrumentation

LC-MS/MS, HPLC, UPLC & QC testing Instruments

Computing skills

  • Word
  • Excel
  • Power Point
  • Outlook

Training Details

  • Regulated Bioanalysis workshop (Requirements & Expectation) by CDER SBIA by 06/2020.
  • DIA - Pharmazone Bioequivalence Bioavailability congress, Future of generic development on 04/11/19 & 04/12/19.
  • Operation & handling training on LC-MS/MS at Waters - Bangalore on 12/20/18 & 12/21/18.
  • Seminar on “An eye-on Data integrity” at PBS on 09/15/17 by Clearsynth.
  • Training course on Watson 7.5 SP1 HF1 at PBS by 11/30/17 to 12/01/17.
  • Participated in training on GLP & GCP annually.

Personal Information

Date of Birth: 05-04-1982

HOBBIES

Cycling, Listen to music & Riding Bike

Disclaimer

I hereby declare that all the information furnished above are true to the best of my knowledge and belief.

Timeline

Asst.Manager (QA)

PAR Biosciences Ltd
04.2014 - 07.2022

Sr.Executive (QC-Bioanalytical)

Syngene International Ltd
07.2010 - 04.2014

QA Chemist

Bafna Pharmaceuticals Ltd
05.2009 - 07.2010

M.Pharm - Pharmaceutical Analysis

Anna University

B.Pharm -

Cherraan's College of Pharmacy

Similar Profiles

CREATE PROFILE
KAMALAKANNAN SUBRAMANI