Product Care support (m/f/d)

Product Care support

m / f / d)

Freelance / temporary employment for a project Basel Land Start date : asap Reference number : 734782 / 1

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Your responsibilities

• Leads a matrix team of experts to support product care of 1-3 commercial combination products and is a member of Technical Product Team
• Establish platform documentation (design control documentation) in application lifecycle software
• Acts as a commercial complaint investigation support, evaluates the annual
• Complaint analysis and supports follow up activities, for example, Root Cause
• Investigations, subsequent Corrective Action and Preventative Actions (CAPA) and Changes (Technical Change Management, Transfers, Capacity Expansion)
• Supports or leads technical Changes Design changes, Introduction of new therapeutic indications, establishing of additional suppliers, Vendor Initiated Change
• Manage the Product Care Annual Review (PCAR)
• Re-) Present PTDE-D in Project Teams, Quality Boards and Governance Bodies, as needed providing Subject Matter Expert (SME) expertise
• Interpret Pharma Quality System requirements into local operational processes

Your profile

• Bachelor / Master Degree (Pharmacy, Pharmaceutical, Bioengineering, Chemistry or other relevant area) and proven track record in the pharmaceutical or related industry
• Demonstrated track record in project management
• Sound knowledge of legislation, regulation, industry standards and guidance within the area of combination products and medical devices
• Self-motivated, pro-active, responsible, result-oriented and an excellent team player
• Experience in working in agile environment and usage of lean tools
• Excellent communication and negotiation skills in German and English (minimum C1 for both languages) with success in building trustful relationships

Your benefits

• A very renowned company
• You will work in an international environment.
Vor 30+ Tagen