QA Validation Lead: GMP Equipment & Systems

Panda International; Breda; On-site; EUR 70,000 - 95,000; Full time

Job summary

Panda International is seeking a QA Validation professional to lead process, equipment and IS validation within a GMP framework. The role provides guidance to operations to ensure policy compliance and quality across projects.

The candidate will review validation documentation, manage changes and participate in QRM activities, ensuring alignment with corporate and regulatory requirements. Strong analytical and collaboration skills are essential.

Qualifications

• Master's degree in Engineering, Pharmaceutical sciences, Process Technology or equivalent.
• 5-8 years GMP experience.
• Relevant experience in Equipment and Automation Validation.
• Proven experience with GMP, equipment and automation/IS validation, computer compliance (Annex 11, Part 11).
• Proven experience with risk management tools such as FMEA, etc.
• Proven experience with statistical tools to support e.g. sampling plans and hypothesis testing.

Responsibilities

• Process, equipment and IS validation in GMP environments.
• Agrees on strategy and provides guidance regarding design, characterization and validation with PD / M&E / IS.
• Reviews and approves validation documentation.
• Maintenance & Engineering support with changes to equipment and M&E procedures.
• Device and combination product responsibilities with GMP alignment.
• Represents QA in QRM activities (pFMEA, QRAES, Computer system compliance).
• Performs final review of technical change controls and QA assessments for changes.

Skills

QA validation

Quality risk management

GMP compliance

Equipment validation

Automation validation

Documentation review

Change control

Regulatory alignment

Education

Master's degree in Engineering

Master's degree in Pharmaceutical sciences

Master's degree in Process Technology

Tools

Statistical tools

Job description

Panda International is seeking a QA Validation professional to lead process, equipment and IS validation within a GMP framework. The role provides guidance to operations to ensure policy compliance and quality across projects.

The candidate will review validation documentation, manage changes and participate in QRM activities, ensuring alignment with corporate and regulatory requirements. Strong analytical and collaboration skills are essential.