QA Officer

About Eurofins PROXY

Eurofins PROXY is part of the internationally operating Eurofins Scientific and is the largest Dutch GMP Quality Control laboratory for the pharmaceutical industry. We specialize in chemical and physical testing for (bio)pharmaceutical raw materials, intermediates, and final products, offering a very diverse package of analytical testing methods for national and international clients within the (bio)pharmaceutical industry.

Are you a quality-driven professional with an eye for detail and a passion for pharmaceutical processes? Then we are looking for you! For our location in Leiden, we are seeking a motivated QA Officer to strengthen our quality team.

Job Description

As a QA Officer, you are responsible for ensuring quality within our laboratory and operational processes. You will work according to GxP, ISO, and internal quality standards and play a key role in documentation control, audits, training, and compliance.

Your responsibilities include:

• Manage and assess deviations, changes, complaints, OOS, and CAPA in accordance with GMP guidelines.
• Maintain and monitor the change control and deviation systems.
• Perform routine quality assurance tasks according to SOPs and quality standards.
• Contribute to the assurance of the quality system based on regulatory requirements (and implementation of regulatory changes).
• Participate in QA system initiatives and improvement projects.
• Train personnel on GMP and quality procedures.
• Conduct (internal) audits and support external inspections (e.g., by regulatory authorities).
• Execute, report, and follow up on self-inspections.
• Create and revise QA procedures and work instructions.
• Maintain the GMP documentation system and archive, including electronic systems.
• Support the creation, review, or updating of QA agreements.
• Manage documentation and compliance related to opiates and precursors.
• Oversee the implementation of new equipment from a QA perspective.
• Ensure compliance in equipment metrology, including documentation.
• Review pest control reports and other facility-related quality documents.

Qualifications

• Bachelor’s degree or above in (bio) Chemistry, Biotechnology, (bio) Pharmacy, (molecular) Biology or related field OR a MBO degree with at least 3 years of experience.
• Minimum of 1 year of experience in the (bio)pharmaceutical industry.
• Minimum of 1 year of experience in a quality oriented environment (GMP / GLP / ISO).
• Organized, structured and accurate.
• High quality awareness.
• Proactive and customer orientated team-player.
• Fluency in Dutch or English; knowledge of both is preferred.
• Knowledge of GMP quality system and regulatory requirements (Eudralex, ICH).
• Knowledge of biological process development and manufacturing is preferred.
• Located in the Netherlands within reasonable distance of our site in Leiden.

Additional Information

PROXY and Eurofins: A world of possibilities

This position is based at Eurofins PROXY on the Bio Science Park in Leiden. We have a close-knit team where collegiality and collaboration come first. We offer a responsible and challenging position within the team with room for your own ideas and input. Working at Eurofins PROXY offers you the flexibility and personal touch of working in a medium sized and dynamic company, whilst also allowing you to benefit from having Eurofins as a parent company. Our ambitious growth plans provide ample opportunities for our employees:

• A competitive salary
• Flexible working hours
• 25 days of vacation with the option to purchase 7 additional days (based on a fulltime contract)
• Travel allowance of 23 cents net per kilometer. Are you traveling by public transport? Then your travel expenses will be fully reimbursed via NS Business Card
• Participation in a pension scheme with 50% contribution by Eurofins
• Each month, you accumulate a choice budget balance of 8.5% of your gross salary. This includes, among other things, holiday pay and a year-end bonus. You can choose to have this amount paid out, or you can use it to buy extra days off, for example. You choose what suits you best
• Discount on additional health insurance
• Tax benefit via FiscFree when purchasing various products and services via your gross salary, such as a bicycle, sports contribution, fitness, mobile telephony, computers & tablets or a weekend away
• Professional training and opportunities for training and development
• Training options via the online learning platform Good Habitz
• Diverse developmental opportunities within the organization
• A large client portfolio ensures a lot of diversity in your work