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"
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