Quality Assurance Officer

The QC Lab of Eurofins Bactimm in Nijmegen is part of the international operating Eurofins Scientific and offers a diverse package of microbiological analyses regarding raw materials and finished products for various national and international clients within the pharmaceutical and medical device industry. The package of microbiological includes performing of bioburden tests, sterility tests, growth promotion tests and indication of microorganisms.

As a Quality Assurance 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.

Responsibilities

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 / setup QA initiatives and improvement projects.; Train personnel on GMP and quality procedures.; Conduct (internal) audits, self inspections and support external inspections (e.g., by regulatory authorities).; 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.; Ensure GxP compliance of the personnel, (validation) studies, facility and equipment from a QA perspective.; Act as deputy for the QA Manager.

Requirements

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 (micro-)biological QC testing is preferred.; Located in the Netherlands within reasonable distance of our site in Nijmegen and in possession of a valid work permit.; Available for a contract of 32 hours a week.