Hays
Basel Stadt | Festanstellung durch unseren Kunden
Referenznummer
558646/1
Meine Aufgaben
  • Develop deep technical understanding of the manufacturing process(es), including an awareness of good manufacturing practices, and industry best practices. 
  • Establish a strong business relationship with key contacts at CM organization(s) to enable remote technical stewardship of processes, and to ensure effective lines of communication are in place.
  • Analyze manufacturing process data on an ongoing basis, to monitor performance with respect to quality, potency and yield using appropriate statistical methods and control charts.
  • Support the investigation of deviation investigations an CMOs. Trend stability data as required.
  • Take ownership for key TS/MS documents, including the process flow document, Internal Alert Limit Assessments, Distribution Temperature Profiles etc.
  • Use data and process knowledge to identify continuous improvement (CI) opportunities. 
  • Participate in annual product review (APR) process, taking ownership for TSMS deliverables, including assessment of ongoing suitability of TS/MS documents. 
  • Update key documents as required. Use data and process knowledge to identify continuous improvement (CI) opportunities. .Liaise with key personnel at the CM, and internal functions (e.g.QA, supply chain and regulatory functions) to deal with day-to-day issues, including, deviation resolution, change management and complaints.
  • Provide technical oversight and leadership, as required, in the implementation of projects, including capital projects, with respect to planning, documentation, commissioning & qualification, training and process/cleaning validation.
  • Ensure appropriate governance is in place for technical changes, through use of the current change management processes.
  • Participate in regular site visits to the CM, to assess ongoing capability and, as required, to support resolution of complex technical issues and/or support implementation of significant process or procedural changes.
  • Participate in joint process team meetings; ensure TS/MS requirements of global contract manufacturing standards are met. Provide TS/MS support as well as leadership for technical transfers as required.
Meine Qualifikationen
  • Minimum of BSc (or equivalent) in relevant discipline, and appropriate experience within pharmaceutical industry.
Meine Vorteile
  • Exciting role
  • Permanent contract
Über Hays
Mit über 15 Jahren Erfahrung in der klassischen Pharmaindustrie ebenso wie in der Biotechnologie und Medizintechnik kennen wir die entscheidenden Ansprechpartner, die anspruchsvolle Aufgaben mit Potenzial ausschreiben. Die hohe Personalnachfrage eröffnet spannende Möglichkeiten für engagierte Experten, um sich beruflich zu entwickeln und an ihrer Karriere zu arbeiten. Ihnen als Kandidat bieten wir dabei als spezialisierte Personalberatung mit einem internationalen Netzwerk entscheidende Vorteile – und das völlig kostenfrei für Sie. Registrieren Sie sich und profitieren Sie von interessanten und passenden Positionen und Projekten.
Mein Kontakt bei Hays

Mein Ansprechpartner
Hannah Wilke

Referenznummer
558646/1

Kontakt aufnehmen
E-Mail: hannah.wilke@hays.ch