Versatile position within quality with growth perspective and opportunities for an experienced QA Officer.
Responsible for planning and execution of daily quality assurance activities while ensuring compliance with international quality requirements as defined by the applicable guidelines (e.g. FDA, EMA, ICH) and all existing GMP standards in the area of responsibility.
Plan and execute quality assurance activities (document management, batch records and label issuance, batch record review, equipment and supplier qualifications etc.) including documentation.
Monitor compliance with all applicable GMP and safety standards.
Support the Qualified Person in his role, including audits and quality training.
Write, review and approve documentation (SOP's, manufacturing and quality instructions, validation of protocols and reports, non-conformity's, change requests). Handle, distribute and archive controlled documents.
Prepare data for trending (QRB, Annual Product Review) and support internal and external audits.
Minimal BSc level education in a relevant field
Several years of experience within QA in the pharmaceutical industry
Experience in a fast pace environment is a plus
You adapt easily in changing circumstances, you are responsible and act pro-active
You are eligble to work in the EU and have either a valid permit or are not required to have one.
Excelent benefit package based on personal experience with a salary up to €65.000
Relocation compensation package