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Associate, Quality Assurance (Supplier Quality)

We are looking for an Associate to join the External Quality Operations team in Hillerod.

Job Category

Quality

Requisition Number

34853BR

Job Description

You will be the Quality Associate for Medicinal Products produced at the labeling and packaging contract manufacturing organizations (CMO) including batch record review and approval of artwork changes.

QA activities related to the labeling and packaging contract manufacturing organizations (CMO) which includes: 
- Preparation of batch records binders for review
- Batch record review
- Contracted by partners for batch record review according to current quality agreements
- Review and approval of change controls
- Review and approval of artwork
- Perform review of release and reject logbooks/register for finished goods
- Update of forms and procedures
- Participate in development and maintenance of Quality Systems as applicable to the manufacturing of medicinal products.
- Ad hoc quality tasks within the department

Qualifications

- Experience preferably as a QA or delegated QP from biotech or pharmaceutical industry
- Knowledge about EMEA and FDA regulations

Education

- Master Degree in Pharmacy or similar


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