Senior Associate, Quality Assurance (Supplier Quality)

Then you might be the person we are looking for! We have an exciting new opportunity for an experienced QA Professional to join our External Quality Operations team in Hillerød.

You will act as our Delegated QP for Medicinal Products produced at the labeling and packaging contract manufacturing organizations (CMO) including batch record review and batch disposition.

Primary Responsibilities

• QA activities related to the labeling and packaging contract manufacturing organizations (CMO) which includes;
• Participate in QA activities for implementing new CMO´s
• Participate in audits and quality meetings
• Lead/participate in QA activities for commercialization of clinical products including preapproval inspection activities.
• Batch record review and batch disposition.
• Perform QA review of batch documentation in relation to Product Complaints or Investigations.
• Perform review of release and reject logbooks/register for finished goods
• Delegated QP for Medicinal Products according to the European Directive 2003/94/EC
• Delegated QA Manager for approval of CAPA’s and Deviations

All operations will be performed as per executed training curricula and under appropriate quality systems such as cGMP, Eudralex, vol 4 or 21 CFR part 820 as described by Biogen procedures

• 3-5 years of experience within QA, QC and/or manufacturing, preferably with some years of experience within QA
• Preferably experience as a delegated QP or QP from biotech or pharmaceutical industry
• Thorough knowledge about EU regulations
• Experie

Are you an experienced Quality Professional with experience working in a dynamic and international environment?