QC Specialist Primary Container Systems (m/f)

REFERENZNUMMER:

258508/11

IHRE AUFGABEN:

-Writing of internal release specifications, derived from existing supply specifications and essential requirements for primary container closure systems, all under the consideration of cGMP requirements
-Responsibility for the adequacy and Good Document Practice of all technical documentation
-Coordinate documents on the basis of existing documentation management systems
-Support the working group by facilitating TCs and workshops and participate actively
-Maintenance of documentation in established systems (e.g. share drive, touch point)
-Support the leader of the working group in administrative activities
-Close cooperation with Direct Material Specification Lifecycle Team

IHRE QUALIFIKATIONEN:

-University level education, preferably with an engineering degree
-First experience in pharmaceutic excipients, primary packaging and/or the medical device industry
-Experience of working in pharmaceuticals or other closely-regulated environments under cGxP, QSR or similar working practices
-Sound knowledge of legislation, regulation, industry standards and guidance around the area of primary container closure systems, combination products and medical devices
-Demonstrable knowledge of primary container closure materials (e.g. glass and elastomers) and Container closure integrity

WEITERE QUALIFIKATIONEN:

Quality manager