Packaging & Labeling Specialist in Biberach an der Riß bei Randstad Deutschland

Our mission: We bring people together! We are currently offering an attractive position as CTSU Packaging & Labeling Specialist with our customer, a pharmaceutical company in Biberach. A fair compensation, personal support and representation by our workers council are of course included. Apply now online! We value equal opportunities and welcome applications from people with disabilities.

Das dürfen Sie erwarten

• Attractive pay accoring to the BAP/DGB collective agreement
• Possibility of takeover by our business partner
• Extensive social benefits, incl. Christmas and holiday bonuses
• Up to 30 days vacation per year
• Representation by a nationwide central works council
• Free online courses, e.g. "German as a foreign language"
• Use of the Randstad App (leave requests online, payroll viewable at any time and much more)

Ihre Aufgaben

• Review of Master Label Text drafts considering regulatory requirements, standard text phrases and trial specifics
• Prepare country specific label text for translation of attending countries
• Review and check translated label text considering local requirements
• Review and check generated print proofs and distribute proofs to countries for check and approval
• Autonomously work in conjunction with CTSU Trial teams, Regulatory Affairs, Global Randomization, Medicine and label vendors to create, define and optimize labeling related tasks
• Hold PLC internal and external Team and pack & label vendors responsible for keeping their timeline and providing overview on the IMP pack & label milestones to the global CTSU trial team as well as ensures appropriate and effective communication to all functions
• Compile and provide completed label documentation for final release to the Release and Process Management Team
• Global PLC-L Specialist provides all relevant Documents like Master Label Text, Country List, Packaging Design, STORM Document and all other country and product specific information necessary to perform this task by external vendors. PLC-L Specialist acts as main contact for vendors and countries
• Contact person for all upcoming questions during the label process

Unsere Anforderungen

• Master’s Degree with experience in a related field or professional training with extensive experience in a related field
• Background in Clinical Trials (Supply Chain, Clinical Trial Regulations, Packaging and Labeling area, medical documentation)
• Experience with labeling needs & processes i. e. Food industry
• Demonstrates knowledge of all areas of clinical supply chain activities and a thorough knowledge and understanding of applicable regulations (e. g. CTR 536/2014)
• Solid project management skills
• Ability to interpret standard and complex project requirements
• Strong problem solving, risk assessment and troubleshooting skills
• Work independently and in a global team environment
• Strong computer skills (e. g. Microsoft Office)
• Fluency in English