QA Specialist

at  Ascendis Pharma

On-siteHellerup, Capital Region of Denmark, DenmarkProduct Supply & Quality, Quality AssuranceFull time1420
Description
Ascendis Pharma A/S, a visionary and ambitious company, offers you an opportunity to become a participant in the further establishment and effective running of QA Commercial Operations. You are offered a position with potential to grow your professional and personal skills and to be part of the introduction of new products to be marketed.
As QA specialist, you will be a part of the well-functioning QA Drug Substance team in the QA Commercial Operations department, with responsibility for quality oversight of starting materials, intermediates, and Drug Substances for commercial products. We have a close collaboration with our Contract Manufacturing Organizations (CMOs) and process- and QC SMEs internally at Ascendis Pharma.

We work with all aspects of quality oversight, i.e., your responsibilities will cover a broad range of tasks, documents, and assignments.
You will serve as primary responsible for oversight of one or more CMOs in our supply chains with respect to review and approval of documentation from these CMOs, including upscale activities, PPQ documentation, CPVs, batch documentation, deviations, changes, CAPAs, stability studies, QMRs, quality agreements etc.
Communication with key personnel at CMOs, including face-to-face meetings, teleconferences, and audits
Participate in CMO evaluations and product quality reviews
You should be able to become QP for Drug Substance.
Keep up to date with changes in relevant product guidelines and regulatory requirements and ensure cGMP at Ascendis and CMOs
Drive and take responsibility in agreed tasks and matters
Continuously optimize our work processes and the way we execute quality oversight