QA / QC Expert (m/f)

REFERENZNUMMER:

341913/11

IHRE AUFGABEN:

-Responsible for the release of product batches and related packaging materials in close cooperation with the QA GMP and Development Manager as delegated by the Responsible Person
-Conduct vendor assessment and/or qualification visits for locally outsourced GxP activities in close collaboration with QA GMP and Development Manager
-Review documentation of incoming batches of medicinal products, and market actions, Review customer, supplier and product master data, Review records of returned goods
-Review relevant global and local Product Quality Reviews (PQRs)
-Ensure that deviations and issues are properly managed in TrackWise System AQWA, including the respect of the escalation process
-Participate in QA Investigation activities as appropriate
-Support implementation and maintenance the local quality system in the areas of GMP, GDP and GPvP
-Provide support to of the CPO and external service providers during and after HA inspections and internal audits
-Ensure that responses to local health authorities have been submitted, commitments have been met and relevant CAPs have been completed/closed

IHRE QUALIFIKATIONEN:

-Profound experience in the pharmaceutical industry in a relevant field such as Quality Assurance, Quality Control
-German and English fluent in speaking and writing, knowledge of French desired
-Knowledge of GMP and ICH guidelines
-MS Office skills, experience with SAP and TrackWise

WEITERE QUALIFIKATIONEN:

Quality manager