Key Skills

Job Description

QC Officer Leiden, Netherlands | 40 hours per week | Permanent position About the role Do you enjoy improving quality systems and helping laboratory teams work in compliance with GMP requirements? Join our QC team and help ensure quality records are handled on time and documentation stays up to date. What will you do? Coordinate the timely handling of deviations, out-of-specification (OOS) results, change controls and CAPAs, including preparation of QC quality records. Monitor and report trends in quality records and training status and represent QC at deviation and change board meetings as needed. Identify bottlenecks in QC quality systems and contribute to quality improvements and cross-functional projects. Maintain QC procedures and work instructions and provide quality-related guidance and training to colleagues. Support internal and external audits by providing documentation and QC quality systems expertise. Monitor relevant regulatory updates, including the European Pharmacopoeia (Ph. Eur.), and support their implementation. Act as back-up for the LIMS administrator when required. Your profile MBO qualification in a biochemical field and three years of relevant work experience. Excellent knowledge of GMP and experience working with quality records and systems. Knowledge of MS Office, electronic quality management systems (eQMS) and LIMS. Strong root cause analysis, analytical thinking and problem-solving skills. Clear communication skills across different organizational levels and a collaborative, accountable approach. We offer Competitive salary, including 13th months and annual reward scheme 25 vacation days (based on a fulltime agreement) 5 additional vacation days NS business card or; Travel allowance by car or bike HAL Allergy, for those who seek pharmaceutical innovation HAL Allergy develops, manufactures and distributes allergen immunotherapies for the treatment and prevention of allergic diseases. Patient well-being is at the heart of our work. More than 300 specialized colleagues collaborate across disciplines in an international pharmaceutical environment. Our headquarters in Leiden brings development, manufacturing and commercial activities together at Leiden Bio Science Park. We offer an informal, diverse working environment where collaboration, initiative and continued development are encouraged. Interested? Let’s connect! Apply directly via Linkedin. Application process Our recruitment process typically includes an interview with the hiring manager and second round with important stakeholders. Depending on the position, an additional interview may be part of the process. Questions? Contact the HR Department via [email protected]

Core Responsibilities

Coordinate QC quality records, including deviations, OOS results, change controls, and CAPAs, and monitor quality and training trends. Maintain procedures, support audits and regulatory updates, provide guidance and training, and contribute to quality improvements and cross-functional projects.

Requirements

Requires an MBO qualification in a biochemical field and three years of relevant work experience. Candidates should have excellent GMP knowledge, experience with quality records and systems, familiarity with Microsoft Office, eQMS, and LIMS, and strong analytical, problem-solving, communication, and collaboration skills.

Benefits

• Competitive Salary
• 13th-Month Payments
• Annual Reward Scheme
• 25 Vacation Days
• 5 Additional Vacation Days
• Public Transport Business Card or Travel Allowance