Description
Our client, a global pharma/biopharmaceutical organisation is currently seeking additional Qualified Persons to join their facility in Austria.The Qualified Persons must have strong experience of finish product release of pharmaceutical products.
Role:
Our client is looking to hire several candidates with experience as a qualified person to support the internal QP team within finished product release.
The responsibilities include:
-As a contracted Qualified Person (QP) or -delegated QP your key responsibilities at the clients facilities include:
-Ensure that an effective pharmaceutical quality management system is operated and that all regulatory obligations of the manufacturing authorization holder are fulfilled
-Perform batch certification, batch release and performance of CAPAs
-Ensure compliance with the conditions of the Marketing Authorization and interact with the regulatory department
-Demonstrate expertise regarding quality assurance (QA), good manufacturing practices (GMP) including good distribution practice (GDP) and quality control (QC) in interactions with clients, authorities, and other interested parties
-Provide QA- and GMP/GDP consultancy
-Provide regulatory input related to manufacturing authorization updates
-Presence during regulatory inspections and involvement in communications with the Inspectors
-Apply high ethical standards and professional conduct with clients and with the Authorities
Skills / Experience
-Strong pharmaceutical / biopharmaceutical experience
-Finished product release experience
-Monitoring of corrective and preventative actions (CAPA)
Education
-Pharmaceutical / Pharmacist / Chemistry or similar Degree
Additional Requirements: German language skills is a must.
This is an exciting opening to work in dynamic team in a short / medium length contract opportunity. Please apply now at or on for more information.