Standaard header
Standaard header

Sr QA-Officer/Qualified Person

Leiden
Are you, as Sr QA Officer within the pharmaceutical industry, ready for your first experience in a QP role? Then this is the job for you!

Bedrijfsnaam

Our client is a GMP accredited contract service organization, specialized in chemical and physical testing and is part of an internationally operating Group.

Locatie

Leiden

Functie omschrijving

You will work as Sr QA-Officer at the QA department of Eurofins Proxy with 12 QA colleagues and will follow a training program to be certified as Qualified Person.

  • You maintain a GMP compliant Quality Management System for manufacturing and quality control of biological drug substances and related final products based on applicable regulations and guidelines.
  • You investigate customer complaints and act as point of contact towards customers for Quality related matters.
  • You host and support customer audits and regulatory inspections
  • You support and coordinate risk assessments.
  • You support and review the qualification of production equipment, test equipment and cleanroom facility.
  • You will review and approve batch records.
  • You will release batches of biological intermediate products, drug substances and related final products (Investigational Medicinal Products).

Profiel kandidaat

As a Qualified Person you like to work in a dynamic environment and your heart beats faster for a great diversity of products. Your excellent communication skills and your strong personality make it easy to connect with the diverse stakeholders in and outside the organisation. You have excellent organisation, facilitating and coordination skills. You will need this to be able to carry and supervise projects in the organisation. And to harvest quality awareness in the company.

Qualifications:
• Master of Science degree in pharmaceutical sciences, chemistry, biochemistry or related discipline;
• Quality Assurance experience in the pharma and/or biotech industry
• Knowledge of GMP quality system and regulatory requirements (Eudralex, ICH)
• Knowledge of biological process development and manufacturing is a real asset
• Fluent in Dutch and English, written and spoken.

Bedrijfsprofiel

Our client is a GMP accredited contract service organization, specialized in chemical and physical testing and is part of an internationally operating Group. The laboratory performs a very diverse range of analyses of raw materials and end products for a large number of national and international customers within the pharmaceutical industry. In addition to this service, they have a separate Business Unit Manufacturing which specialises in Contract Manufacturing Organisation activities, such as aseptic fill of medication for pre-clinical and phase I and II Clinical Trials. In addition, they also carry out small-scale commercial productions. This Business Unit consists of 11 employees.

Inloggen

MY Recruitment gebruikt cookies om bepaalde voorkeuren te onthouden en vacatures af te stemmen op je interesses.