Quality Assurance Specialist
TR/080440
Posted: 06/01/2026
- Competitive
- Netherlands, Provincie Noord-Brabant, Breda
- Contract
Orion Group Life Sciences are currently recruiting a Quality Assurance Specialist on behalf of our Multinational Biopharmaceutical Client based in Breda on an initial 12-Month contract with potential to extend.
Perform QA support and oversight for validation of equipment, automation and information systems.
Perform review and approval of equipment and automation validation documentation, ensuring that Corporate, Site and Regulatory requirements are met.
Provide guidance and direction to operations staff in regards to compliance with quality policies, standards and procedures.
Provide quality engineering support for testing strategies and quality investigations.
Responsibilities
Process, equipment and IS validation
Agrees on strategy and provides guidance regarding design, characterization and validation in cooperation with PD / M&E / IS, while ensuring GMP quality and compliance.
Reviews and approves validation documentation.
Maintenance & Engineering support
Reviews and approves changes to equipment (e.g. parameter changes, like for like assessments, …)
Reviews and approves changes to M&E procedures (e.g. change over process, preventive and corrective maintenance)
Device and combination product
Manages ABR’s device responsibilities and ensures alignment with GMP regulations.
Quality Risk Management (QRM)
Represents QA in QRM activities (pFMEA, QRAES, Computer system compliance)
Ensures alignment of site Quality Risk activities with corporate policy and strategy.
Reviews quality risk assessment reports.
Change control
Performs final review of technical change controls, confirming assessments of different stakeholders are complete and all tasks are correctly represented in the record.
Functions as QA SME and collects input from different QA areas to complete the QA assessment for technical changes.
Minimum Requirements
Master degree in Engineering, Pharmaceutical sciences, Process Technology or equivalent
5-8 years of professional experience in GMP environment
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.
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Perform QA support and oversight for validation of equipment, automation and information systems.
Perform review and approval of equipment and automation validation documentation, ensuring that Corporate, Site and Regulatory requirements are met.
Provide guidance and direction to operations staff in regards to compliance with quality policies, standards and procedures.
Provide quality engineering support for testing strategies and quality investigations.
Responsibilities
Process, equipment and IS validation
Agrees on strategy and provides guidance regarding design, characterization and validation in cooperation with PD / M&E / IS, while ensuring GMP quality and compliance.
Reviews and approves validation documentation.
Maintenance & Engineering support
Reviews and approves changes to equipment (e.g. parameter changes, like for like assessments, …)
Reviews and approves changes to M&E procedures (e.g. change over process, preventive and corrective maintenance)
Device and combination product
Manages ABR’s device responsibilities and ensures alignment with GMP regulations.
Quality Risk Management (QRM)
Represents QA in QRM activities (pFMEA, QRAES, Computer system compliance)
Ensures alignment of site Quality Risk activities with corporate policy and strategy.
Reviews quality risk assessment reports.
Change control
Performs final review of technical change controls, confirming assessments of different stakeholders are complete and all tasks are correctly represented in the record.
Functions as QA SME and collects input from different QA areas to complete the QA assessment for technical changes.
Minimum Requirements
Master degree in Engineering, Pharmaceutical sciences, Process Technology or equivalent
5-8 years of professional experience in GMP environment
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.
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Jordan Robb
Recruitment Consultant
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