QA Specialist (equipment & system validation) - Undutchables

Jobster; Breda; On-site; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Career development

Travel reimbursement

30 holidays

Undutchables contract

Competitive salary

Job summary

Jobster is seeking a QA Specialist to provide quality oversight for validation and lifecycle management of equipment, automation, and information systems in a GMP environment.

You will review technical documentation, advise on GMP requirements, and ensure quality considerations are embedded in technical decisions across multiple departments.

Qualifications

• Master's degree in Engineering, Pharmaceutical Sciences, Process Technology or a comparable field.
• Approximately 5–8 years of professional experience within a GMP environment.
• Experience with equipment, automation and/or information system validation.
• Knowledge of EU GMP Annex 11 and FDA 21 CFR Part 11.
• Experience with Quality Risk Management tools such as FMEA.
• Experience using statistical methods to support sampling plans and hypothesis testing.

Responsibilities

• Review equipment, automation and information system validation documentation.
• Provide QA guidance on design, characterization and validation of equipment and systems.
• Ensure validation activities comply with GMP, internal quality standards and regulatory requirements.
• Review and approve technical changes to equipment, including parameter changes and like-for-like assessments.
• Review changes to Maintenance & Engineering procedures, including preventive/corrective maintenance and changeover processes.
• Provide quality engineering support for testing strategies, investigations and technical quality issues.
• Support QA activities related to devices and combination products and ensure alignment with GMP requirements.
• Represent QA in Quality Risk Management activities, including FMEA and other risk assessments.
• Review Quality Risk Assessment reports to keep site activities aligned with policies.

Skills

GMP knowledge

Equipment validation

Automation validation

Quality risk management

Statistical methods

FMEA

Education

Master's degree (Engineering/Pharma/Process Technology)

Job description

Please note before applying: Only candidates with a valid work permit for the Netherlands will be considered for this role. This role does NOT offer sponsorships options.

As QA Specialist, you will provide quality oversight for the validation and lifecycle management of equipment, automation and information systems. You will review technical documentation, advise different departments on GMP requirements and ensure that quality and compliance considerations are incorporated into technical decisions.

Responsibilities

• Reviewing and approving equipment, automation and information system validation documentation.
• Providing QA guidance regarding the design, characterization and validation of equipment and systems.
• Ensuring validation activities comply with GMP, internal quality standards and regulatory requirements.
• Reviewing and approving technical changes to equipment, including parameter changes and like-for-like assessments.
• Reviewing changes to Maintenance & Engineering procedures, including preventive and corrective maintenance and changeover processes.
• Providing quality engineering support for testing strategies, investigations and technical quality issues.
• Supporting quality activities related to devices and combination products and ensuring alignment with applicable GMP requirements.
• Representing QA in Quality Risk Management (QRM) activities, including FMEA and other quality risk assessments.
• Reviewing Quality Risk Assessment reports and ensuring site activities remain aligned with corporate quality policies and strategies.
• Performing the final QA review of technical change controls, ensuring assessments and required actions are complete.
• Acting as a QA subject-matter expert for technical changes and coordinating input from different Quality areas.

This is a position with a high level of independence and responsibility. You will work with minimal supervision and manage several assignments and processes simultaneously. You will independently determine the appropriate approach for your projects while working toward defined operational and project objectives. Ultimately, your work contributes to delivering validated systems that meet corporate, site and regulatory requirements.

Requirements

• A Master's degree in Engineering, Pharmaceutical Sciences, Process Technology or a comparable field.
• Approximately 5-8 years of professional experience within a GMP environment.
• Relevant experience with equipment and automation validation.
• Strong knowledge of GMP requirements.
• Experience with equipment, automation and/or information system validation.
• Knowledge of computerized system compliance requirements, including EU GMP Annex 11 and FDA 21 CFR Part 11.
• Experience with Quality Risk Management tools such as FMEA.
• Experience using statistical methods to support activities such as sampling plans and hypothesis testing.

Nice to have

• Previous experience within the pharmaceutical industry.
• Experience working with nonconformances, CAPAs and Change Control.

Benefits

• A challenging work environment with excellent career development programs.
• For this role, the company offers a competitive salary package.
• Reimbursement of travel expenses is dependable on travel distance.
• 30 Holidays.
• contract through Undutchables.