QA Specialist

Undutchables; Breda; On-site; EUR 69,000 - 71,000; Full time

Benefits offered by this job

Travel reimbursement

30 holidays

Contract via Undutchables

Job summary

Undutchables zoekt een QA Specialist om kwaliteitsbewaking te leveren tijdens validatie- en lifecycle-management van equipment, automatisering en informatiesystemen. U beoordeelt technische documentatie en adviseert afdelingen over GMP-vereisten, zodat kwaliteit en compliance zijn verankerd in technische beslissingen.

Belangrijke verantwoordelijkheden omvatten goedkeuren van validatiedocumenten, advies geven bij ontwerp en validatie, en zorgen voor compliance met GMP en regelgeving.

Qualifications

• Voldoende kennis van GMP-vereisten.
• Ervaring met validatie van apparatuur en automatisering.
• Kennis van EU GMP Annex 11 en FDA 21 CFR Part 11 is een pluspunt.
• Kennis van statistische methode zoals sampling en hypothesetesten.

Responsibilities

• Beoordelen en goedkeuren validatiedocumenten voor apparatuur, automatisering en informatiesystemen.
• Geven QA-advies over ontwerp, karakterisering en validatie van apparatuur en systemen.
• Zorgdragen voor naleving van GMP, interne kwaliteitsnormen en regelgeving.
• Ondersteunen bij technische wijzigingen aan apparatuur en change controls.
• Ondersteunen van QA-activiteiten met betrekking tot apparaten en combinatieproducten.

Skills

Engels

Education

Master's degree in Engineering or Pharmaceutical Sciences

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.

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.

Salarisomschrijving

€6200 - €6400 monthly

Vaardigheden

• Er is geen minimale opleiding vereist
• Je beheerst Engels

Wat wij bieden

€6.200,- tot €6.400,-