Freelance QA Validation Officer to Write Protocols

Vivid Resourcing; Antwerpen; On-site; EUR 69,000 - 96,000; Full time

Job summary

Vivid Resourcing is seeking a freelance QA Validation Officer in Antwerp for a hands-on role focused on validating protocols and ensuring compliance with GMP requirements. You will prepare and execute validation activities, maintain documentation, and support CAPAs and change controls across QA, Engineering, and Production teams.

The role requires strong technical writing, attention to detail and ability to work independently in a cross-functional environment.

Qualifications

• Minimum 3 years of experience in validation, qualification or QA within a GMP-regulated pharmaceutical or biotechnology environment.
• Proven hands-on experience writing and executing validation protocols.
• Strong knowledge of GMP regulations and validation lifecycle principles.

Responsibilities

• Write, review and execute validation and qualification protocols, including IQ, OQ and PQ.
• Prepare validation documentation, including Validation Plans, URS, Risk Assessments and Validation Reports.
• Support qualification and validation of manufacturing equipment, processes, utilities and systems.
• Ensure validation activities are performed in compliance with EU GMP, Annex 15 and internal procedures.
• Execute validation testing on-site with accurate documentation and full traceability.
• Identify, document and investigate deviations arising during protocol execution.
• Support CAPAs, change controls and validation-related quality events.
• Review executed protocols and compile final validation reports.
• Collaborate with QA, Engineering, Production and Validation teams to ensure timely completion.
• Maintain inspection-ready GMP documentation.
• Support continuous improvement initiatives related to validation procedures and quality compliance.

Skills

Validation

GMP

Documentation

IQ/OQ/PQ

Quality Assurance

Job description

For a GMP customer in Antwerp, we are searching for a freelance QA Validation Officer to be responsible for the preparation, review and execution of validation protocols, ensuring all activities are performed in accordance with GMP requirements and internal quality standards.

This is a hands-on validation role requiring strong technical documentation skills, practical protocol execution experience and a solid understanding of quality and compliance within a regulated pharmaceutical environment.

Responsibilities

• Write, review and execute validation and qualification protocols, including IQ, OQ and PQ.
• Prepare validation documentation, including Validation Plans, User Requirement Specifications (URS), Risk Assessments and Validation Reports.
• Support the qualification and validation of manufacturing equipment, processes, utilities and associated systems.
• Ensure validation activities are performed in compliance with EU GMP, Annex 15 and internal quality procedures.
• Execute validation testing on-site, accurately documenting results and ensuring full traceability.
• Identify, document and investigate deviations arising during protocol execution.
• Support the management of CAPAs, change controls and validation-related quality events.
• Review executed protocols and compile final validation reports.
• Work closely with Quality Assurance, Engineering, Production and Validation teams to ensure timely completion of validation activities.
• Maintain accurate, complete and inspection-ready GMP documentation.
• Support continuous improvement initiatives relating to validation procedures and quality compliance.

Profile

• Minimum 3 years of experience in validation, qualification or QA within a GMP-regulated pharmaceutical or biotechnology environment.
• Proven hands-on experience writing and executing validation protocols is essential.
• Strong knowledge of GMP regulations, EU GMP Annex 15 and validation lifecycle principles.
• Experience with IQ/OQ/PQ qualification activities and associated documentation.
• Good understanding of deviations, CAPAs, change control and quality management systems.
• Experience working in a pharmaceutical manufacturing or GMP production environment.
• Strong technical writing skills and excellent attention to detail.
• Ability to work independently and collaborate with cross-functional teams.

SENIORITY: Medior/Senior

START DATE: December/January

DURATION: 12 Months

EXTENSION: Yes

CONTRACT: Freelance

ONSITE POLICY: Flexible

HOURS PER WEEK: 40

LANGUAGES: Fluent English and Dutch

INTERVIEW PROCESS: 1 stage