Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
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Indrajeet Ravi Menon

Dublin 13

Summary

Detail-oriented senior quality control Analyst with 4+ years of experience in creation and review of quality documents, training of staff on empower and GDP, and inspection of analytical batch records of finished products in a cGMP environment with focus on Good Laboratory practices and Good Documentation practices to meet regulatory compliance.

Overview

10
10
years of professional experience

Work History

Senior Quality Control Analyst

Viatris Dublin Respiratory
06.2022 - Current
  • Managed team of 4 analysts on shifts to ensure testing and release plans are met.
  • Segregation of samples for stability and pulling these samples as per stability protocols.
  • Provided training on improved processes, CAPA and assisted with creation and review of training materials like OJT
  • Consulted manuals, sop, method and process documents to investigate OOS and OOT.
  • Participated in departmental meetings to establish short- and long-term strategy and evaluation of same during constant intervals.
  • Performed writeup, proofing and review of validation reports to improve clarity and quality of work.
  • Analyzed quality and performance data to support operational decision-making.
  • Compiled and distributed weekly feedback to supervisor and manager to improve service time and quality while increasing productivity.
  • Addressed non-conformance issues, pausing testing to correct errors.

Quality Control Analyst

Viatris (t/a Mylan Dublin Respiratory)
04.2019 - Current
  • Perform testing and data review within required timeline and in compliance with guidelines
  • Maintain strict compliance with all safety regulations, standard operating procedures and good Documentation practices
  • Utilize six sigma yellow belt training to perform root cause analysis and design investigational tests due to laboratory unexpected results
  • Conducted laboratory investigations and generated reports in response to invalids and deviations along with raising and implementing CAPA's
  • Training for Quality control personnel
  • Identified and implemented lab process improvements
  • Stock control - Maintaining laboratory reagents stock and supplies
  • Participated in filling, packaging, and labeling of drug products and device while adhering to Quality standards as outlined in Standard Operating Procedure
  • Performed Calibration, in-process and parameter checks, Cleaning and Maintenance of all equipment/rooms used in manufacture process while reporting any issues to site manager
  • Worked in 24/7 Shift basis in cGMP Environment
  • Formulating and Evaluating Pharmaceutical Formulations (Tablets, Capsules, semi-solids, Ampoule) using Lab Scale Equipment
  • Handling and validation of Pharmaceutical equipment's in Lab
  • Creating and updating Standard operating procedures and work instructions
  • Evaluate/troubleshoot routine and non-routine technical or analytical issues including instrument related problems.

Manufacturing Operator

Viatris (t/a Mylan Dublin Respiratory)
09.2018 - 04.2019
  • Participated in filling, packaging, and labeling of drug products and
    device while adhering to Quality standards as outlined in Standard
    Operating Procedure.
  • Performed Calibration, in-process and parameter checks, Cleaning and
    Maintenance of all equipment/rooms used in manufacture process
    while reporting any issues to site manager.
  • Worked in 24/7 Shift basis in cGMP Environment.
  • Inspected products and machines to maintain quality and efficiency
  • Operated machining equipment safely with team of operators
  • Followed detailed instructions to operate machines with accuracy and produce quality products

Assistant Professor

Nehru College of Pharmacy
08.2013 - 05.2017
  • Formulating and Evaluating Pharmaceutical Formulations (Tablets,
    Capsules, semi-solids, Ampoule) using Lab Scale Equipment.
  • Handling and validation of Pharmaceutical equipment's in Lab.
    Creating and updating Standard operating procedures and work
    instructions.
  • Evaluate/troubleshoot routine and non-routine technical or analytical
    issues including instrument related problems.
  • Collected data for performance outcomes for training programs provided.
  • Proctored exams and provided remediation for learning improvement goals

Education

MSc Pharmaceutical Business And Technology - Pharmaceutics

Griffith College
Dublin
09.2018

Master of Science - Pharmaceuticals

Nehru College of Pharmacy
Kerala
07.2013

Bachelor of Science - Bachelor of Pharmacy

St James College of Pharmacy
Kerala
04.2011

Skills

  • Trackwise
  • LIMS
  • Empower Trainer and Reviewer
  • Stability pull
  • Complaints analysis
  • Lean Six Sigma
  • Quality Control
  • Process Improvement
  • Attention to Detail
  • Communication skills
  • Analytical Methods
  • CGMP Regulations

Accomplishments

  • Performed validation on specific API and brought back testing to the main lab from the contract lab, which had a positive impact on the lab's yearly expenses.
  • Provides Empower training for analyst and reviewers.
  • Supervised evening shift to ensure testing performed consistently in order to ensure the release dates are met.

Timeline

Senior Quality Control Analyst

Viatris Dublin Respiratory
06.2022 - Current

Quality Control Analyst

Viatris (t/a Mylan Dublin Respiratory)
04.2019 - Current

Manufacturing Operator

Viatris (t/a Mylan Dublin Respiratory)
09.2018 - 04.2019

Assistant Professor

Nehru College of Pharmacy
08.2013 - 05.2017

MSc Pharmaceutical Business And Technology - Pharmaceutics

Griffith College

Master of Science - Pharmaceuticals

Nehru College of Pharmacy

Bachelor of Science - Bachelor of Pharmacy

St James College of Pharmacy

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Indrajeet Ravi Menon