Dr. Daniela Heller

Chargenfreigabe von Arzneimitteln (Lyophilisate, Injectabilia, feste Arzneiformen), Bewertung von Abweichungen, Reklamationen, Change Control Anträgen; Verbesserung der Qualitätssicherungssysteme in Teamarbeit; Begleitung von Transferprojekten; Prüfung und Genehmigung von Herstell- und Methodenvalidierungsplänen und -berichten; Durchführung von Lieferantenaudits

Qualified Person §15 AMG (Market Release of Drug Products)

Leading of the department with 15 direct reports; responsible for schedule and in-time execution of follow-up stabilities; Development and Validation of analytical methods;

The position "Head of Quality Control" is mentioned in the German law (AMWHV). In Addition to my responsibilities as Senior Specialist Bulk / Finished Goods the notification to the local health authority as "Head of Quality Control Bulk and Semi Finished Goods" authorizes myself to release bulk batches and semi finished goods from Quality Control. Futhermore it authorizes myself to release product Batches from Quality Control in substitution of our Head of Quality Control Finished Goods.

Teamlead function in Quality Control, Releases of Bulk, semi-finished goods and finished goods from Quality Control (Head of Quality Control acc. German drug law (AMWHV) since 02/2014); OOS Management, Complaint Management in Quality Control and responsibility for pharmacist education.

Head of the department Documentation & Compliance within quality assurance with the main job tasks quality systems and document management incl. SOPs, Quality Manual and Site Master File, Non-Conformance and CAPA Management, Complaint Handling System, Change Control System, Product Quality Review, Internal Audits, Issue of batch certificates, Attendence of Inspections; since April 2010 stellv. Stufenplanbeauftragte (deputy QP Pharmacovigilance)

Manager of the department quality systems / compliance within quality assurance with the main job tasks document management incl. SOPs, Batch Documentation incl. Batch Record Review, Non-Conformance and CAPA Management,, Complaint Handling System, Issue of batch certificates, Attendence of Inspections; since April 2010 stellv. Stufenplanbeauftragte (deputy QP Pharmacovigilance)

Pharmacist within the field of mail order business; Management of the call center and Implementation of quality assurance systems