Packaging & Labeling Specialist (m/w/d) (RE
Für unseren Kunden, ein pharmazeutisches Unternehmen in Marburg, suchen wir ab sofort einen
Packaging & Labeling Specialist (m/w/d)
in Arbeitnehmerüberlassung mit Übernahmeoption:
Position Purpose
The Manager of Packaging & Labeling is a key role within a global team. This role is responsible together with a team of Packaging & Labeling Specialists to ensure that our products are specifically packaged and labeled for global clinical study programs.This role has to ensure that the study medication is labeled in compliance with the regulatory requirements of the countries participating in the clinical studies.
The role is also responsible to provide a packaging design, which meets the needs of our patients, the study sites and the study protocol.
Main Responsibilities and Accountabilities:
- Responsible that study medication will be labeled, packaged and released according to the timelines of the clinical study.
- Responsible to set up and maintain processes to provide translated and regulatory compliant label text for all countries participating in global clinical study programs.
- Responsible for the development and maintenance of a label text phrase library and ensure standardization and harmonization across the clinical studies.
- Responsible for the development and maintenance of label layout standards for study medication.
- Ensure sufficient inventory of all packaging materials and labels to meet clinical study needs.
- Consult the CTS study teams as expert for the development of innovative packaging and label design solutions.
- Act as expert regarding clinical study labeling regulations.
- Contribute to the development, implementation and usage of effective and efficient system solutions and processes for the packaging, labeling and release of study medication at CSL Behring and/or external service providers.
- Represent the Packaging & Labeling team in case of inspections or audits.
- Ensure that packaging & labeling related reports are available, which provide status information as well as inventory oversight.
- Provide and maintain meaningful KPI reports.
- Contribute to meet the financial targets of the global CTS organization.
- Develop Standard Operating Procedures and working instructions for packaging and labeling processes.
- Responsible that findings and deviations are processed within the agreed timelines
Position Qualifications and Experience Requirements
- College degree (BSc, MSc, Diploma) in a life science discipline, engineering or project management.
- Other degrees and certifications considered if commensurate with related clinical research or clinical supply management experience.
- Professional experience of 5+ years with at least 3-4 years in clinical supply management, clinical logistics or R&D project management
Competencies
- Very good understanding of clinical trial supply processes
- Strong knowledge of SAP and supply packaging processes
- Very good knowledge of international clinical labeling regulations
- Very good knowledge of GMP, GDP and GCP regulations
- Strong written and oral communication skills
- Very good presentation skills
- Strong organizational and time management skills
- Ability to work in a matrix structure
- Good global project management skills
- English fluent; Level 2
- German; good
Details:
- employment type: employed contract model
- location: Marburg, Hesse, Germany
- start: asap
- end: June 2020
- full time
Fragen zur Stelle beantworte ich gerne unter +49 (0) 69 264 89 8075.
Falls nicht, freue ich mich über Kontakte aus Ihrem Netzwerk, für die dieses Projekt interessant sein kann.
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