Crucell is a global biotech company that focuses on the development, pro­duction and marketing of vaccines, recombinant proteins and antibodies to prevent and combat infectious and other diseases.

Within Crucell talented, entrepreneurial people are working in a dynamic cul­ture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Crucell:

                           Senior Quality Assurance Officer Technical Support

Department/Project:
The Quality Assurance Department verifies whether the activities in Crucell Leiden comply with the applicable GxP standards (GMP, GLP, GRP, GDP).

Job Description:
· Participate in evaluating the current Crucell quality systems and implement improvements to comply with the current FDA standards.
· Drafting procedures to cover current and future demands on quality approach.
· Assess and report cGMP implications on introducing new equipment and processes in the current cGMP environment. Translate these implications into procedures and validation approaches.
· Participate in the review of validation, calibration and maintenance related documents (e.g. validation protocols, validation reports, calibration sheets).
· Participate in the review of technical changes, deviations and procedures.
· Assist the QA Validation Coordinator in maintaining the Validation System.
· Execute batch review process of Quality Assurance.
· Assist the Qualified Person in batch release process.
· Provide training on GxP subject to Crucell staff.
· Support regulatory inspections and client audits.
· Execute internal and external audits.

Minimum Qualifications:
·Bachelor’s or Masters degree in a relevant area
Dutch, English, both fluently spoken and written
Thorough knowledge of cGMP and Validation
5 Years relevant working experience in pharmaceutical or biotechnology company of which preferably 3 years in manufacturing, QC or QA, experience with GMP inspections.

Competences:
Communicative skills
Convincing
Team player
Accuracy