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Labeling Manager (m/w/d) (EN)
[13493]
Labeling, Regulatory Affairs
Job title: Labelling Manager (m/w/d) Industry: Pharma Skills: Labelling, Regulatory Affairs Start of project: 01.09.2023 Duration of the project : 12 Months Project volume: 0 Hour(s) Location: Zurich Qualifications: The ideal candidate has minimum a bachelor’s degree and/or at least 2 years’ experience in the clinical supplies space (packaging/ labelling operations). • The individual must possess excellent communication skills • Excellent organizational skills, time management skills • Very good German and English skills • Able to work independently • Analytical thinking • Eye for detail • Able to work in the GMP environment • Team player Responsibilities: The primary activities include but are not limited to: • Creation and approval of label text translations with the aid of systems (Clinical Label Proof Generator and the electronic document database). • Creation and approval of the translations and corresponding documents with regards to the study-specific, company-internal and country-specific regulatory requirements. • Creation and monitoring of the project schedule and coordination of projects from the label translation to the delivery of the labels to the packaging department. • Ensures through effective project management that the communication to the relevant locations is guaranteed at all times and the project requirements can be met. • Consultation of the responsible project manager with regards to the determination of the label text in compliance with international regulatory requirements and internal company standards. • Provides input and partners with other work centers to develop the packaging/labelling strategy for the individual clinical products in regards of label text. • Participates regularly in internal and global coordination meetings • Maintenance of the label generation documentation according to GMP Standards. • Review of label generation documents according to study specific and regulatory requirements. Good Manufacturing Practices and Compliance in general: Follows workflows and procedures according to current SOPs Working time: Working time starts between 8-9h. There are some regular meetings with counterparts in US in the afternoon (estimated to be approx. 3-5h./week). Commuting: The candidate is expected to work 2-3 days/week on-site.
Skills: Labelling, Regulatory Affairs
Qualifications:
The ideal candidate has minimum a bachelor’s degree and/or at least 2 years’ experience in the clinical supplies space (packaging/ labelling operations).
• The individual must possess excellent communication skills
• Excellent organizational skills, time management skills
• Very good German and English skills
• Able to work independently
• Analytical thinking
• Eye for detail
• Able to work in the GMP environment
• Team player
Responsibilities:
The primary activities include but are not limited to:
• Creation and approval of label text translations with the aid of systems (Clinical Label Proof Generator and the electronic document database).
• Creation and approval of the translations and corresponding documents with regards to the study-specific, company-internal and country-specific regulatory requirements.
• Creation and monitoring of the project schedule and coordination of projects from the label translation to the delivery of the labels to the packaging department.
• Ensures through effective project management that the communication to the relevant locations is guaranteed at all times and the project requirements can be met.
• Consultation of the responsible project manager with regards to the determination of the label text in compliance with international regulatory requirements and internal company standards.
• Provides input and partners with other work centers to develop the packaging/labelling strategy for the individual clinical products in regards of label text.
• Participates regularly in internal and global coordination meetings
• Maintenance of the label generation documentation according to GMP Standards.
• Review of label generation documents according to study specific and regulatory requirements.
Good Manufacturing Practices and Compliance in general: Follows workflows and procedures according to current SOPs
Working time: Working time starts between 8-9h. There are some regular meetings with counterparts in US in the afternoon (estimated to be approx. 3-5h./week).
Commuting: The candidate is expected to work 2-3 days/week on-site.
Bella Iglesias