Open to opportunities

Irina K

@irinak

Quality Assurance Specialist with 10+ years improving GMP/GDP quality systems across pharma, medical devices, and cosmetics.

India

Message

What I'm looking for

I want to grow within quality teams where I can strengthen ISO/GMP/GDP Quality Management Systems, lead audits and CAPA, and partner cross-functionally to improve compliance, documentation, and supplier performance in a fast-paced environment.

I’m a Quality Assurance Specialist and Engineer with 10+ years of experience in Quality Management Systems across Cosmetics production, Medical equipment manufacturing, and Pharmaceutical marketing. I develop, implement, and maintain quality systems compliant with ISO 9001, ISO 13485, GMP, and GDP, and I’m known for driving results through supplier assessments, audits, deviations, and corrective action ownership.

At Johnson & Johnson (Janssen Pharmaceutical), I ensured postproduction process compliance, led internal audits, managed Deviations and CAPA end-to-end, and drove Change Control from impact assessment to timely completion. I also strengthened document control using Veeva Vault, used TrackWise daily to manage quality processes, and supported regulatory activities for new product launch, certification, and release; previously, I handled nonconformances, supplier quality complaints, and root-cause investigations in medical devices and cosmetics environments.

Experience

Work history, roles, and key accomplishments

Senior Business Quality Specialist

Johnson & Johnson - Janssen Pharmaceutical

Jun 2018 - Jul 2020 (2 years 1 month)

Ensured compliance of postproduction processes and drug quality by leading audits, supplier assessments, and quality agreements for contractors and 3PLs. Managed deviations and CAPA end-to-end, led change control, and supported complaints, temperature excursion investigations, and regulatory activities.

GMP GDP CAPA Change Control Supplier Audits Trackwise Root Cause Analysis

Supplier Quality Engineer

ConvaTec - Medical Devices Production

Mar 2016 - Mar 2018 (2 years)

Managed nonconformances and CAPA in TrackWise from initiation to closure, including supplier material quality complaints and corrective action effectiveness checks. Conducted negative trend analysis, supported nonconformance review board activities, and contributed quality metrics for management review.

Trackwise CAPA Quality Non Conformance Supplier Quality Root Cause Analysis Trend Analysis Complaints Handling Quality

Quality Engineer

JV Stilmark - Cosmetics Production

Mar 2011 - Mar 2016 (5 years)

Performed incoming inspections for raw materials, packaging, and labels, and conducted functional inspections throughout cosmetics production to ensure quality and compliance. Raised nonconformity reports, performed root cause analysis, and drove corrective actions to prevent defects and improve product quality.

Inspections Root Cause Analysis Documentation Control