QA Validation & Risk Lead - GMP Equipment & Automation

Panda International; Breda; On-site; EUR 65,000 - 95,000; Full time

Job summary

Panda International in Breda, Netherlands, seeks a QA professional to provide QA support for validation of equipment, automation and IS, and to lead Quality Risk Management activities. You will review validation docs, ensure GMP compliance, and guide operations on quality policies.

The role requires 5–8 years in GMP, experience with FMEA, Annex 11/Part 11, and change control. You will act as QA SME across projects and ensure alignment with corporate standards.

Qualifications

• Master degree or equivalent in Engineering, Pharmaceutical sciences, or related field.
• 5-8 years of professional GMP experience in equipment and automation validation.
• Proven experience with GMP, equipment and automation/IS validation, and computer compliance (Annex 11, Part 11).
• Experience with risk management tools such as FMEA, etc.
• Proven experience with statistical tools to support sampling plans and hypothesis testing.

Responsibilities

• Provide QA support and oversight for validation of equipment, automation and information systems and for Quality Risk Management.
• Review and approval of validation documentation ensuring compliance with corporate, site and regulatory requirements.
• Provide guidance to operations staff regarding compliance with quality policies, standards and procedures.
• Quality engineering support for testing strategies and quality investigations.

Skills

Quality Assurance

GMP compliance

Validation

Risk management

Documentation

Education

Master degree in Engineering, Pharmaceutical sciences, Process Technology or equivalent

Tools

FMEA

Statistical tools

CSV tools

Job description

Panda International in Breda, Netherlands, seeks a QA professional to provide QA support for validation of equipment, automation and IS, and to lead Quality Risk Management activities. You will review validation docs, ensure GMP compliance, and guide operations on quality policies.

The role requires 5–8 years in GMP, experience with FMEA, Annex 11/Part 11, and change control. You will act as QA SME across projects and ensure alignment with corporate standards.