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

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.

Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:

ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.

We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.