Summary
Overview
Work History
Education
Skills
Certification
Accomplishments
Languages
Timeline
Generic

Janny Coca Armas

Brampton,ON

Summary

Bilingual quality assurance specialist with over a decade of experience in pharmaceutical manufacturing, quality investigations, and CAPA management. Expertise in conducting thorough site-level reviews and assessments of deviations, complaints, CAPAs, and investigation reports, ensuring adherence to scientific rigor and compliance with cGMP, FDA, and Health Canada standards. Proven track record in coaching and training cross-functional teams, fostering strong partnerships that drive continuous improvement and standardization of investigation processes while upholding organizational values and business ethics. Committed to enhancing quality systems and promoting a culture of excellence within the industry.

Overview

29
29
years of professional experience
1
1
Certification

Work History

Senior QMS Investigator, Quality Assurance

SGS Canada Inc
03.2022 - Current
  • Lead lab investigations ensuring alignment with Global and Health Authority expectations and corporate standards across all QA documentation and processes.
  • Conduct site-level, real-time review, evaluation, and approval of deviations, change controls, complaints, OOS investigations, and CAPAs, applying scientific rigor and regulatory standards to ensure sustainable, consistent quality of investigations prior to closure.
  • Utilize standardized rubrics and templates to assess investigation reports, ensuring root cause analysis, risk and impact assessment, and effective CAPA proposals.
  • Coach and mentor more than 10 QA staff and investigators, reinforcing best practices in investigation and CAPA processes, and supporting continuous improvement and standardization across the site.
  • Host and support client, regulatory, and corporate audits/inspections (Health Canada, FDA), managing CAPA follow-up and contributing to zero observation outcomes.
  • Develop site audit plan and conduct internal audits, and vendor qualification audits and track CAPA effectiveness, supporting continuous improvement and regulatory compliance.
  • Prepare and present metrics, KPIs, and investigation trends to global management, supporting data-driven decision-making and site surveillance initiatives.

Investigator, Quality Assurance

QMS
03.2017 - 03.2022
  • Led and documented laboratory investigations, including non-conformances and product quality failures, ensuring root causes were accurately identified and corrective actions were effective and sustainable.
  • Managed CAPA commitments and effectiveness checks, increasing compliance and on-time closures through robust tracking and trending.
  • Updated SOPs and investigation templates to align with global standards and regulatory changes, strengthening site investigation processes and supporting IAC evaluation-based education.

QC Chemist

Apotex Inc
07.2011 - 02.2017
  • Performed and reviewed analytical testing and documentation for in-process, stability samples and finished pharmaceutical products, ensuring cGMP and regulatory compliance.
  • Conducted non-conformance investigations and collaborated with QA, R&D, Stability, and Manufacturing teams to deliver compliant, scientifically sound resolutions.
  • Supported continuous process improvement and standardization of documentation practices throughout the site.

Research Lab Manager

Fisheries Research Centre
10.2007 - 12.2009
  • Led scientific research and reporting, evaluated lab technology, and ensured alignment with regulatory standards and budgetary requirements for the Ministry of Fisheries.

University Professor/Researcher

Higher Polytechnic Institute "José Antonio Echeverría"
09.1996 - 09.2007
  • Taught and mentored over 500 students in scientific reasoning, process analysis, and investigation methodologies; led research and published peer-reviewed findings.

Education

Ph.D. - Technical Science

Higher Polytechnic Institute "José Antonio Echeverría"
01.2002

M.Sc. - Engineering of Biotechnological Processes

Higher Polytechnic Institute "José Antonio Echeverría"
01.1998

B.Sc. - Chemical Engineering

Higher Polytechnic Institute "José Antonio Echeverría"
01.1996

Skills

  • CGMP, FDA, Health Canada Regulatory Expertise
  • Advanced expertise in GMP investigations, root cause analysis, and CAPA management
  • Site-level real-time review, assessment, and approval of deviations, complaints, and investigations
  • Scientific reasoning, critical thinking, and disciplined documentation practices
  • Strong interpersonal, communication, presentation, and facilitation skills
  • Effective coaching, mentoring, and feedback delivery to support self-teaching and continuous improvement
  • Proficient in Electronic Quality Management Systems (Trackwise)
  • Audit Management (Corporate, client, Regulatory)
  • Proficient in Spanish (native) and English (advanced)

Certification

ASQ Certified Quality Auditor (CQA) – Credential ID 72718, Expires Dec 2027

Accomplishments

  • Supported Health Canada and FDA inspections (2019, 2023) with zero observations and no 483s received.
  • Consistently closed over 90% of client audits (2019–2023) by ensuring robust investigation follow-up and CAPA execution.
  • Key contributor to successful implementation and training of QMS TrackWise module, updating SOPs and investigation templates for enhanced site compliance and knowledge transfer.

Languages

Spanish
Native or Bilingual
English
Full Professional

Timeline

Senior QMS Investigator, Quality Assurance

SGS Canada Inc
03.2022 - Current

Investigator, Quality Assurance

QMS
03.2017 - 03.2022

QC Chemist

Apotex Inc
07.2011 - 02.2017

Research Lab Manager

Fisheries Research Centre
10.2007 - 12.2009

University Professor/Researcher

Higher Polytechnic Institute "José Antonio Echeverría"
09.1996 - 09.2007

M.Sc. - Engineering of Biotechnological Processes

Higher Polytechnic Institute "José Antonio Echeverría"

B.Sc. - Chemical Engineering

Higher Polytechnic Institute "José Antonio Echeverría"

Ph.D. - Technical Science

Higher Polytechnic Institute "José Antonio Echeverría"
Janny Coca Armas