Specialist QA

QA Specialist - Validation & Quality Systems
Are you an experienced QA professional with a strong background in equipment, automation and computerized system validation? For an international pharmaceutical manufacturing environment, we are looking for a QA Specialist who will provide quality oversight across technical projects, validation activities and Quality Risk Management.
In this role, you will work closely with Engineering, Manufacturing, Process Development and IT/IS teams. You will ensure that equipment, automated systems and technical changes meet GMP requirements as well as internal and regulatory quality standards.
Your role
As a QA Specialist, you will act as the Quality representative for validation, engineering and technical change activities. You will review and approve documentation, provide guidance on compliance requirements and support teams in making risk-based quality decisions.
Your responsibilities include:

• Providing QA oversight for the validation of equipment, automation and computerized/information systems;
• Reviewing and approving validation protocols, reports and other technical documentation;
• Advising project and operational teams on validation strategy, system design and GMP compliance;
• Reviewing and approving technical changes to equipment, parameters and engineering procedures;
• Supporting Maintenance & Engineering with quality-related assessments for preventive and corrective maintenance activities;
• Acting as QA Subject Matter Expert for technical Change Controls;
• Ensuring that stakeholder assessments and required actions within Change Controls are complete and correctly documented;
• Representing QA during Quality Risk Management (QRM) activities, including FMEA and other risk assessments;
• Reviewing Quality Risk Assessment reports and ensuring alignment with site and corporate quality requirements;
• Supporting investigations, testing strategies and other quality engineering activities;
• Supporting quality requirements related to devices and combination products.

You will work independently across multiple projects and assignments, determining the appropriate quality approach while ensuring agreed objectives and timelines are achieved.

What you bring

• A Master’s degree in Engineering, Pharmaceutical Sciences, Process Technology or a comparable technical/scientific discipline;
• Approximately 5-8 years of professional experience within a GMP-regulated environment;
• Strong experience with equipment and automation validation;
• Experience with computerized system compliance and relevant regulations such as EU GMP Annex 11 and 21 CFR Part 11;
• Good understanding of validation principles, qualification and Quality Risk Management;
• Experience with risk management methodologies such as FMEA;
• Experience using statistical tools to support activities such as sampling plans and hypothesis testing;
• Strong analytical skills and the ability to assess complex technical and quality-related situations;
• Excellent communication and documentation skills;
• The ability to work independently while collaborating effectively with multidisciplinary teams.

Experience within the pharmaceutical industry and knowledge of deviations/nonconformances, CAPA and Change Control are considered strong advantages.
What makes you successful in this role?You are able to maintain a broad overview while diving into technical details when necessary. You combine strong quality awareness with a pragmatic and risk-based mindset and are comfortable challenging, advising and supporting stakeholders across different departments.
You enjoy working in a highly regulated environment where quality, patient safety and continuous improvement are central to everything you do.