Associate Qualified Person
vor 5 Monaten
Schönefeld, Germany
**Job ID** R0000012666
**Category** Clinical Logistics
**ABOUT THIS ROLE**:
We have an exciting opportunity for an **Associate Qualified Person. **You will provide direction to PLD, PM&D and LQM which includes mentoring and training of GxP relevant topics and the supervision of Quality Management projects.
**You will serve as a quality consultant to designated operational group(s) and will be responsible for**:
- Identification of process improvement opportunities.
- Process authoring and review, support for process re-engineering
- Provide GxP and process expertise to designated operational group(s)
- Support for identification, management, and prevention of quality issues and assist with the collection and reporting of quality metrics as assigned
**Key responsibilities also include that**:
- Each batch of investigational medicinal products manufactured in or imported into the Union complies with the requirements set out in Article 63 of REGULATION (EU) No 536/2014 and Article 13.3 of Directive 2001/20/EC and your role is to certify that those requirements are fulfilled.
- Medicinal products manufactured within the European Union have been manufactured and checked within the boundaries of national law and the requirements of the Marketing Authorization (MA) or Clinical Trial Application for IMP.
- Critical quality attributes of each IMP are understood and that the QP has sufficient knowledge about each IMP to perform the Batch Certification.
- Batch certification is recorded in a register or equivalent document.
- Batch certification is only performed after confirmation that each production batch was manufactured and tested according to EU-GMP.
- Delegation of any QP-tasks is performed only to another Qualified Person(s).
- Release of Investigational Medicinal Products (IMP) is performed according to clinical trial regulations, in accordance with agreed protocols, the principles of International Conference on Harmonization, Good Clinical Practice and Good Manufacturing Practice.
- Guidance on technical and regulatory requirements for the conduct of clinical trial is given, as well as advice on GxP-issues.
- A Quality Management System is in place that safeguards that correct procedures in the process for assembly and supply of study medication (investigational medicinal products) are followed.
- A Quality Management System is in place that safeguards that Quality Control procedures are in place and followed.
- Internal and external audits are assisted including supplier qualification audits (e.g. supplier providing starting materials for production activities).
- Direct reports are adequately advised, instructed, and managed in accordance with the internal processes relevant for a Parexel line manager.
- Acts as a backup Head of Quality Control EUDC in case of absence (holidays, sick leaves, etc.) of one of the main HQCs EUDC.
**Skills, Knowledge and Experience**
- Excellent knowledge about EU and global GMP, GCP and GDP regulations
- Experience with EU QP-Batch Certification and Release procedure of IMP
- Excellent bio-pharmaceutical knowledge and product understanding of current IMPs and IMPs in the development pipelines (e.g. Cell and Gene Therapy Products)
- Experience with Import & Export of pharmaceutical products
- Experience in Quality Control, Quality Assurance, Quality Systems, Quality Compliance and Quality Improvement required
- GMP / GDP auditing experience
- Authority Inspection experience
- Project management and leadership abilities: Six Sigma LEAN Green Belt or above
- Experience in Quality Control and Quality Assurance required
- Ability to think and work globally and be culturally aware
- Ability to handle several highly complex projects/tasks simultaneously, potentially spanning different Strategic Business Units
- Ability to act as the main quality interface with clients
- Customer-focused in defining and establishing priorities
- Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and new learning
- Ability to manage multiple and varied tasks with enthusiasm
- Ability to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organization
- Ability to travel as needed for the position
**Language Skills**
- Must have fluent speaking, written & verbal skills in German and English
**Education**
- Fulfilment of qualification as per -15 AMG (as interpreted by local authority LAVG in Brandenburg, Germany):
- Registered Pharmacist in Germany
- Practical experience over a period of at least two years, in one or more companies authorized to manufacture medicinal products in the EU, covering qualitative and quantitative analysis of medicinal products
- PhD degree preferred
-
Associate Qualified Person
vor 6 Monaten
Dresden, Deutschland Parexel VollzeitWe have an exciting opportunity for an **Associate Qualified Person. **You will provide direction to PLD, PM&D and LQM which includes mentoring and training of GxP relevant topics and the supervision of Quality Management projects. **You will serve as a quality consultant to designated operational group(s) and will be responsible for**: - Identification of...
-
Lead Qualified Person
vor 6 Monaten
Dresden, Deutschland PCI Pharma Services VollzeitLife changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Main purpose of job: Leading the PCI Berlin...
-
Sachsen: Qualified Person
vor 6 Monaten
Dresden, Deutschland Triga Consulting GmbH & Co KG VollzeitFür unseren Kunden mit Standorten Sachsen - suchen wir derzeit Sie als Qualified Person (m/w/d) Aufgaben - Verantwortung als Sachkundige Person - Prüfung und Freigabe von Produkten gemäß gesetzlichen Anforderungen - Koordination von abteilungsübergreifenden Projekten - Schulung der Mitarbeiter - Mitwirkung bei Projekten Qualifikation -...
-
Sachkundige Person/ Qualified Person
vor 5 Monaten
Dresden, Deutschland Octapharma VollzeitStellen-ID: 57450- Standort: Dessau-Rosslau, DE- Karrierestufe: Experte- Fachbereich: Quality- Beschäftigungstyp: Festanstellung- Karrierestufe: Octapharma ist ein weltweit tätiges Unternehmen und unterstützt mit seinen Produkten Patient:innen in 118 Ländern weltweit. Unsere Medikamente sind qualitativ hochwertige Humanproteine, die aus Humanplasma und...
-
Head of Brr
vor 6 Monaten
Dresden, Deutschland Triga Consulting GmbH & Co KG VollzeitFür unseren Kunden ein deutsches, international erfolgreiches Unternehmen mit Spezialisierung im Pharmabereich - suchen wir derzeit Sie als Head of BRR & Qualified Person (m/w/d) Aufgaben - Sachkundige Person gemäß - 15 AMG zur routinemäßigen Freigabe von Bulkwaren und Fertigarzneimitteln - Durchsetzung der GMP-Regeln in allen GMP relevanten...
-
Associate International Due Diligence
vor 5 Monaten
Dresden, Deutschland Bridge of Hope Vollzeit**Associate International Due Diligence / Project Risk Manager (M/F/d)** - Onsite / Mobile / Full-time_ My client is one of the leading project developers for renewable energies in Germany. The group's project pipeline currently exceeds 19 gigawatts across all its markets. Through its operational management company, it also takes over the operational...
-
Research Associate biochemistry
vor 2 Monaten
Dresden, Deutschland Open Sesame Therapeutics GmbH Vollzeit**Open Sesame Therapeutics GmbH** is a dynamic biotech start-up based in Dresden, focused on developing delivery systems for macromolecule therapeutics. Currently operating in stealth mode to protect its innovations in this early phase, the company was founded by **Prof. Marino Zerial and Dr. Ivan Baines** as a spin-off from the **Max Planck Institute for...
-
Teamleiter Produktion/ Production Supervisor
vor 5 Monaten
Dresden, Deutschland American Axle & Manufacturing VollzeitAt AAM, the POWER is in our people. We believe that an equitable and inclusive workplace benefits everyone and that the diversity of our Associates drives creativity and innovation. Our global team of associates is made of dreamers, doers and innovators who are Bringing the Future Faster by Delivering POWER for a safer, brighter and more sustainable...
-
Research Associate
vor 5 Monaten
Dresden, Deutschland Leibniz-Institut für Polymerforschung Dresden e. V. VollzeitTUD Dresden University of Technology, as a University of Excellence, is one of the leading and most dynamic research institutions in the country. Founded in 1828, today it is a globally oriented, regionally anchored top university as it focuses on the grand challenges of the 21st century. It develops innovative solutions for the world's most pressing issues....
-
Research Associate
vor 6 Monaten
Dresden, Deutschland Technische Universität Dresden VollzeitTechnische Universität Dresden (TUD), as a University of Excellence, is one of the leading and most dynamic research institutions in the country. Founded in 1828, today it is a globally oriented, regionally anchored top university as it focuses on the grand challenges of the 21st century. lt develops innovative solutions for the world's most pressing...
-
Research Associate
vor 6 Monaten
Dresden, Deutschland Leibniz-Institut für Polymerforschung Dresden e. V. VollzeitTUD Dresden University of Technology, as a University of Excellence, is one of the leading and most dynamic research institutions in the country. Founded in 1828, today it is a globally oriented, regionally anchored top university as it focuses on the grand challenges of the 21st century. It develops innovative solutions for the world's most pressing issues....
-
Research Associate
vor 5 Monaten
Dresden, Deutschland Leibniz-Institut für Polymerforschung Dresden e. V. VollzeitTUD Dresden University of Technology, as a University of Excellence, is one of the leading and most dynamic research institutions in the country. Founded in 1828, today it is a globally oriented, regionally anchored top university as it focuses on the grand challenges of the 21st century. It develops innovative solutions for the world's most pressing issues....
-
Research Associate
vor 4 Wochen
Dresden, Deutschland Technische Universität Dresden VollzeitTUD Dresden University of Technology, as a University of Excellence, is one of the leading and most dynamic research institutions in the country. Founded in 1828, today it is a globally oriented, regionally anchored top university as it focuses on the grand challenges of the 21st century. It develops innovative solutions for the world's most pressing issues....
-
Research Associate
vor 5 Monaten
Dresden, Deutschland Leibniz-Institut für Polymerforschung Dresden e. V. VollzeitTUD Dresden University of Technology, as a University of Excellence, is one of the leading and most dynamic research institutions in the country. Founded in 1828, today it is a globally oriented, regionally anchored top university as it focuses on the grand challenges of the 21st century. It develops innovative solutions for the world's most pressing issues....
-
Research Associate
vor 5 Monaten
Dresden, Deutschland Technische Universität Dresden VollzeitTUD Dresden University of Technology, as a University of Excellence, is one of the leading and most dynamic research institutions in the country. Founded in 1828, today it is a globally oriented, regionally anchored top university as it focuses on the grand challenges of the 21st century. lt develops innovative solutions for the world's most pressing issues....
-
Research Associate
vor 6 Monaten
Dresden, Deutschland Leibniz-Institut für Polymerforschung Dresden e. V. VollzeitTUD Dresden University of Technology, as a University of Excellence, is one of the leading and most dynamic research institutions in the country. Founded in 1828, today it is a globally oriented, regionally anchored top university as it focuses on the grand challenges of the 21st century. It develops innovative solutions for the world's most pressing issues....
-
Research Associate
vor 5 Monaten
Dresden, Deutschland Technische Universität Dresden VollzeitTechnische Universität Dresden (TUD), as a University of Excellence, is one of the leading and most dynamic research institutions in the country. Founded in 1828, today it is a globally oriented, regionally anchored top university as it focuses on the grand challenges of the 21st century. lt develops innovative solutions for the world's most pressing...
-
Research Associate
vor 6 Monaten
Dresden, Deutschland Leibniz-Institut für Polymerforschung Dresden e. V. VollzeitTUD Dresden University of Technology, as a University of Excellence, is one of the leading and most dynamic research institutions in the country. Founded in 1828, today it is a globally oriented, regionally anchored top university as it focuses on the grand challenges of the 21st century. It develops innovative solutions for the world's most pressing issues....
-
Research Associate
vor 5 Monaten
Dresden, Deutschland Technische Universität Dresden VollzeitTUD Dresden University of Technology, as a University of Excellence, is one of the leading and most dynamic research institutions in the country. Founded in 1828, today it is a globally oriented, regionally anchored top university as it focuses on the grand challenges of the 21st century. It develops innovative solutions for the world's most pressing issues....
-
Research Associate
vor 6 Monaten
Dresden, Deutschland Leibniz-Institut für Polymerforschung Dresden e. V. VollzeitTechnische Universität Dresden (TUD), as a University of Excellence, is one of the leading and most dynamic research institutions in the country. Founded in 1828, today it is a globally oriented, regionally anchored top university as it focuses on the grand challenges of the 21st century. lt develops innovative solutions for the world's most pressing...
