Services

Senior GMP expertise,
delivered flexibly

Tailored to your timelines, team, and regulatory context. Available as project-based engagements or ongoing retainer.

01

QMS Design and Improvement

Compliant, clear, and user-focused quality management systems.

Well-written SOPs and well-designed QMS are the backbone of a functional quality system. I develop and review GMP-compliant documentation tailored to your specific processes, equipment, and regulatory framework — whether ICH, EU GMP, FDA 21 CFR, or ISO standards.

Includes

  • ◆SOP drafting and revision
  • ◆Batch record design
  • ◆Document gap analysis
  • ◆Template standardization
  • ◆Document lifecycle management
02

GMP Training

Practical, engaging training for operators, QA teams, and management.

Compliance is built through understanding, not memorization. I design and deliver GMP training programs that connect regulatory requirements to everyday practice — adapted for your team's role and experience level.

Includes

  • ◆GMP fundamentals for new staff
  • ◆Data integrity workshops
  • ◆Deviation & CAPA handling
  • ◆Train-the-trainer programs
  • ◆Training effectiveness assessment
03

Remote QA Support

On-demand quality expertise without the overhead of a full-time hire.

Whether you need support during audit preparation, a batch crisis, or a period of high workload — I provide experienced, responsive remote QA assistance including deviation investigations, CAPA plan review, and batch record assessment.

Includes

  • ◆Deviation investigation support
  • ◆CAPA plan review
  • ◆Batch record assessment
  • ◆Audit preparation & mock audits
  • ◆Change control management
04

QA Transformation

Building quality systems that are efficient, digital, and future-proof.

Drawing on experience implementing digital QMS and OPEX initiatives at Lonza, I guide quality transformation projects — from process mapping and gap analysis to system selection, change management, and go-live support.

Includes

  • ◆Digital QMS implementation
  • ◆Process optimization (Lean / OPEX)
  • ◆KPI dashboard design
  • ◆Gap analysis vs. GMP standards
  • ◆Change management support
Get Started

Let's discuss your project

All engagements start with a free 30-minute scoping call.

Contact Me