QA Specialist (equipment & system validation) - Undutchables

Jobster; Breda; On-site; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Competitive salary package

30 holidays

Travel expense reimbursement depending

Contract through Undutchables

Job summary

Jobster in the Netherlands seeks a Senior QA Engineer to lead validation activities for equipment, automation and information systems in a GMP setting. You will guide design, characterization and validation efforts and ensure compliance with EU GMP Annex 11 and FDA Part 11, while coordinating QA input across multiple projects.

Independent and responsible, you will review technical changes, support testing strategies, and align quality activities with corporate policies.

Qualifications

• Master's degree in Engineering, Pharmaceutical Sciences, Process Technology or comparable field.
• Approximately 5–8 years of professional experience within a GMP environment.
• 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.

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.

Skills

Quality engineering

FMEA

Statistical methods

Education

Master's degree in Engineering, Pharmaceutical Sciences, 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.

Your main responsibilities include:

• 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.