QA Validation Specialist | Breda | Hybrid

Description

This role provides QA oversight for equipment, process, and automation/IS validation activities within a GMP manufacturing environment. The position focuses on reviewing and approving validation documentation, supporting technical change controls, deviations, and ensuring data integrity within the electronic batch record system (PASX).

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Sectors

Pharmaceuticals, Medical Devices

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Company Size & Type

Large pharmaceutical manufacturing site (GMP-regulated)

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Must Have Requirements

• MBO or Bachelor’s degree in Life Sciences, Process Technology, or related field

• Minimum 3 years’ experience in the pharmaceutical or medical device industry

• Hands-on experience with Equipment and Automation / IS Validation

• Strong working knowledge of GMP

• Knowledge of Annex 11 & 21 CFR Part 11 (computer compliance)

• Experience reviewing and approving validation documentation

• Experience with electronic batch record systems (PASX or similar)

• Fluent in English

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Desirable Requirements

• Experience in pharmaceutical manufacturing environments

• Experience with Change Control processes

• Experience with Deviation Management

• Exposure to device or combination product environments

• Knowledge of quality engineering tools and risk-based approaches

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Responsibilities

Process, Equipment & IS Validation

• Agree on validation strategies in collaboration with PD, M&E, and IS

• Provide QA guidance on design, characterization, and validation activities

• Review and approve validation documentation in line with GMP and regulatory requirements

Maintenance & Engineering Support

• Review and approve equipment changes (e.g. parameter changes, like-for-like assessments)

Device & Combination Products

• Manage QA responsibilities related to device aspects within ABRs

• Ensure alignment with applicable GMP regulations

PASX Master Data

• Review and approve master data in the PASX electronic batch record system as QA

Change Control

• Perform final QA review of technical change controls

• Confirm completeness of stakeholder assessments and task representation

• Act as QA SME and consolidate input from relevant QA areas

Deviation Management

• Act as QA contact for deviation records

• Support quality investigations and testing strategies

Interested? Send your cv to Daria at d.finikova@panda-int.com or call +31202044502 for more info.