Project Manager Technical Documentation (m/f)

REFERENZNUMMER:

260557/11

IHRE AUFGABEN:

-Compile technical documentation
-Prepare supplier specifications for direct materials (chemicals, non-formulating materials, excipients, active pharmaceutical ingredients/ API)
-Develop project plans, prioritizing and meeting targets and timelines
-Ensure compliance with most current revisions (ISO, DIN, ICH etc.), applicable pharmacopeias (EP, JP, USP etc.)
-Reviewing risk assessments (design/system FMEA's) considering cGMP requirements
-Responsibility for Good Document Practice/ GDP of all technical documentation incl. maintenance of established documentation using management systems (Documentum)
-International travel up to 20%

IHRE QUALIFIKATIONEN:

-University level (Bachelor, Master, or equivalent) education, preferably with an natural sciences or engineering degree
-Track record and experience in pharmaceutics, excipients, primary packaging- and/or medical device industry
-Experience of working under cGxP, QSR or similar working practices
-Sound knowledge of industry standards around the area of primary container closure systems, combination products and medical devices
-Demonstrable knowledge of specifications, statistical techniques, process capability, testing based on pharmacopoeia, risk assessments
-Excellent command of English & German, Spanish and/or Italian is a major plus
-Excellent documentation skills
-Excellent collaborative, interpersonal, communication skills
-IT and documentation knowledge

WEITERE QUALIFIKATIONEN:

Project manager, Medical writer