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At STADA we pursue our purpose “Caring for people‘s health as a trusted partner” worldwide. Originally founded by pharmacists, we are a leading manufacturer of high-quality pharmaceuticals. More than 12,300 employees around the globe live our values Integrity, Entrepreneurship, Agility and One STADA to achieve ambitious goals and shape the successful future of STADA.

 

Our global Headquarter, STADA Arzneimittel AG, is located in Bad Vilbel near Frankfurt am Main. To strengthen our team we are looking for a


Quality Manager (f/m/d), Qualified Person Cannabis and Narcotics Officer 

Bad Vilbel | Germany (DE) | Full-time | Permanent 

 

Your responsibilities:

 

  • Support and Management of the quality requirements of the Cannabis business in STADA on a Global Basis
  • Ensure of production, testing storage of narcotics including reference and reserve samples in compliance with the narcotics regulations
  • Ensure of supply, acquisition, import and export of narcotic drugs in compliance with the regulations of narcotics law
  • Implementation of orders from the supervisory authorities regarding BtM
  • Support the Director of Commercial QA Germany in the creation of the half-yearly report according to §18 BTMG
  • Application for permission according to §3 BTMG or notification of changes
  • Act as a competent person (QP) as required
  • Ensuring compliance with the legal requirements at the respective national and EU level as well as the establishment and maintaining of the Commercial Quality Germany unit
  • Act as the Responsible Person under the Distribution Licenses held within Germany
  • Support the creation of the Commercial Quality organization in accordance with Global Quality requirements
  • Establish the current strengths and weaknesses of the Quality Systems within the German Commercial Affiliates
  • Development and implementation of the Global QMS within the German Commercial Affiliates as well as establish regular communication governance with the Commercial Affiliates
  • Ensure that Corporate Procedures and Standards are properly deployed in to the local QMS and managed accordingly
  • Development, Implementation and Maintenance of the Quality Management System (QMS) covering GMP /GDP requirements, regulations and standards related to the scope of the local business
  • Provide oversite on deviations, corrective and preventive actions and change controls

 

Your qualifications:

 

  • University degree/diploma in the field of Science or equivalent
  • Several years of professional experience in the pharmaceutical industry (> 10 years)
  • Qualification as a competent person in accordance with Section 15 (1) AMG
  • Previous experience working as a narcotics officer is preferable
  • Understanding of the GxP requirements associated with the supply of cannabis products
  • Appropriate competence and experience as well as strong knowledge of and training in Good Distribution Practice (GDP), Good and Manufacturing Practice (GMP)
  • Experience of the development and maintenance of a quality management system at a local and regional level
  • Strong understanding of Good Distribution Practice of medicinal products for human use (2013/C 343/01 and regulation 45 of the Human Medicines Regulations 2012)
  • In-depth knowledge of national pharmaceutical legislation and the EU guidelines, in particular market approval
  • Very good knowledge of BtMG, BtMBinHV, BtMAHV, BtMVV
  • Business fluent English required, German is a big plus

 

Are you looking for new challenges where you can make a difference for people’s health? We are looking for candidates with expert knowledge and an entrepreneurial spirit that enjoy working collaboratively in a global team. We would be pleased get to know you. Please use our online job portal to submit your application: jobs.stada.com

Apply now »