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Head Drug Product Manufacturing (m/f) Job ID: 10558

Ihre Aufgaben
  • Set up the team and facility for production of clinical trials and commercial-scale DP production

  • Set-up of Quality systems in Production Department in close collaboration with the Quality Unit to ensure cGMP compliance with special emphasis to EMA and US FDA requirements

  • Coordinate issue identification and corrective action plans and implement such plans to meet GMP requirements, resolve project 'issues' and maintain business commitments

  • Ensure introduction and implementation of state-of-the-art technologies to facilitate therapeutic biologics production

  • Active participation in process development to ensure possibility to transfer technology to production

  • May represent the company in partnerships/joints development committees and professional societies

  • Monitor the production processes and process quality and make improvements as needed

  • Manage, among other things, stock levels to meet production requirements, warehousing facility and logistics, mechanical reliability programs, supply chain budget, stock control and inventory levels of obsolete and slow moving stock, energy consumption, site security, waste generation & disposal, standard operating procedures, monthly inventory variance and all necessary performance documentation for employees on site (including identification of training needs)

  • Performing all duties with respect to current GMP requirements and other pharmaceutical regulations

  • Represent the company during regulatory inspections

  • CapEx and operational budget responsibility

Auf Anfrage
Auf Anfrage
Larissa Weber
Fon +49 89 416 117 0 – 0
Mobil + 49 152 295 555 62
Larissa Weber
Fon +49 89 416 117 0 – 0
Mobile + 49 152 295 555 62
Mail larissa.weber@theentourage.de
Betreff Bewerbung für Job ID 10558 auf theentourage.de