QA Specialist Eurofins BioPharma Product Testing

About the company Eurofins Bio Pharma Product Testing B.V. is part of the international operating Eurofins Scientific. The organization is the largest Dutch contract laboratory for the pharmaceutical industry. We […]

About the company

 
Eurofins Bio Pharma Product Testing B.V. is part of the international operating Eurofins Scientific. The organization is the largest Dutch contract laboratory for the pharmaceutical industry. We specialize in analytical tests for (bio) pharmaceutical raw materials, intermediates and (bio) pharmaceutical products. We perform a very diverse range of analyses for a large number of national and international clients within the (bio) pharmaceutical industry.

Job description:

As QA Specialist you maintain a GMP compliant Quality Management System for the manufacturing and testing of raw materials and (biological) drug products based on applicable regulations and guidelines. You will have a diverse role in a high-paced environment, interacting with both our customers and internal staff.

Responsibilities:

• Investigating customer complaints and act as point of contact towards customers for Quality related matters;
• Review, assess and approve (complex) investigations related to deviations, non-conformances and out of specifications;
• Review and release of certificates of analysis, reports, materials, equipment and internal data;
• Review facility and environmental monitoring;
• Organize, host and support customer audits and regulatory inspections;
• Support and coordinate risk assessments;
• Review and approve batch records;
• Assist in maintenance and development of the QMS;
• Promote the awareness of quality, regulatory and customer requirements throughout the company;
• Lead and coordinate QA improvement projects;
• Act as deputy of the QA Manager.

Qualifications

• Bachelor or Master of Science degree in pharmaceutical sciences, chemistry, biochemistry or related discipline;
• Minimum of 2 years of experience in a GMP environment;
• Preferably experience with facility qualification and release;
• Knowledge of GMP quality system and regulatory requirements (Eudralex, ICH);
• Knowledge of biological process development and manufacturing is preferred;
• Organized work processes / set priorities;
• Strong decision making and problem-solving skills;
• Team player, able to work with all levels in the organization;
• Positive mind set;
• High level of integrity;
• Fast learner;
• Fluent in English, written and spoken.

Link to vacancy:

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