As Qualified Person (QP) (all genders) - fulltime, permanent for drug products manufactured or tested in Ludwigshafen (batch certification for bulk and finished drug products) you ensure that all required quality standards are maintained.

You are responsible for assessment and batch certification of bulk and finished drug products as Qualified Person (Annex 16 EU directive and §16 AMWHV, according to German Law) which are manufactured in Ludwigshafen.

Responsibilities:

• Ensuring compliance of APIs, excipients and packaging materials used for production of drug products manufactured in Ludwigshafen in all aspects of compliance.
• Act as Qualified Person for drug products manufactured or tested in Ludwigshafen (batch certification for bulk and finished drug products).
• Perform Batch certification for bulk and finished drug products.
• Review of documents, e.g. Investigation Protocols, Deviations protocols, Complaint reports and other GMP relevant reports. Provide directions and support on investigations, complaint reports and other quality improvement topics.
• Review Product Specification, Test Protocols, Batch Records, and if necessary, initiation of revisions.
• Assessment of general GMP documents and QTAs.
• Represent AbbVie Quality Assurance with external sites or customers.
• Training and education of pharmacist trainees (according to German Drug Law)