Product Care support

Product Care support (f/m/d)

Product Care support (f/m/d) - project management / chemistry/ Health Authority / pharma / German**

Project:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Product Care support

Background:
Within the department, the chapter Product Care team is accountable for Technical Support of marketed Combination Products and Medical Devices, Post Launch Changes, Complaints and DHF Maintenance, input to APQR/PSQR, Remediations.

The perfect candidate:
The perfect candidate brings excellent communication and negotiation skills in German and English (minimum C1 for both languages) with success in building trustful relationships. Additionally, he or she is self-motivated, pro-active, responsible, result-oriented and an excellent team player.

Tasks & 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 e.g. Design changes, Introduction of new
• therapeutic indications, establishing of additional suppliers, Vendor Initiated Change
• Manage the Product Care Annual Review (PCAR)
• Ensuring regulatory compliance and Roche internal GMP standards (e.g.
• departmental archiving concept, records management and training)
• Interpret Pharma Quality System requirements into local operational processes
• Support internal/external Quality/Regulatory/SGU inspections
• (Re-) Present PTDE-D in Project Teams, Quality Boards and Governance Bodies, as
• needed providing Subject Matter Expert (SME) expertise
• Continuous optimization of performance and striving for excellence
  Must Haves:

Bachelor/Master Degree (Pharmacy, Pharmaceutical, Bioengineering, Chemistry or other relevant area) and proven track record in the pharmaceutical or related industry

• 5

• 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

Nice to Have:

• Experience with Health Authority interactions

Reference Nr.: 923085SGR
Role: Product Care support
Industry: Pharma
Workplace: Basel & Kaiseraugst
Pensum: 100%
Start: 01.02.2024
Duration: 12++

Deadline : 17.12.2023