Beschreibung
Quality Manager within IMP Quality Clinical Packaging (m/f/d) - cGMP /Pharma / SAP / English / GermanProject:
For our customer a big pharmaceutical company based in Kaiseraugst we are looking for a highly qualified Quality Manager within IMP Quality Clinical Packaging (m/f/d)
Background:
IMP Quality Operations Switzerland is responsible for delivering Investigational Medicinal Products ("IMPs") to our patients in compliance with cGMP. We are the Quality Partner for all Manufacturing Units and Clinical Packaging in Pharmaceutical Technical Development in Switzerland and responsible for the Quality and Compliance oversight of all. We are committed to transform ourselves from the inside out towards a purpose driven organization based on strength and role based working. We do this in order to create a great place to work, so each of us can thrive and to unleash our full potential.
The perfect candidate:
The roles within IMP Quality Operations Switzerland Clinical Packaging Team requests a high level of flexibility, ability to work under pressure and sense of responsibility. You are inspiring, self-reflected and creative on the one hand and are clear in communication as well as integrative in solution processes on the other. You support the end-to-end cGMP activities, maintaining the Right to Operate at the Clinical Packaging Site in Kaiseraugst, ensure the quality of IMP products to meet Health Authority requirements and Company Standards for IMP products. In this role you are assigned as delegate of the Swiss Responsible Person for IMPs (Fachtechnisch verantwortliche Person, FvP), and within that role, you are responsible for the lot disposition and certification of IMPs finished products.
Tasks & Responsibilities:
- Support all quality-relevant packaging processes and collaborate with packaging operations and all relevant interfaces with regard to GMP topics
* Partner with stakeholders and provide GMP support to ensure successful delivery of the company goals
* Review and release of manufacturing specifications and Batch Records (BR) of finished and semi-finished goods
* Manage actively Deviations and Changes
* Collaboration through to the management of local and global projects
* Actively engage in optimization activities and improvements within IMP Quality Clinical Packaging Switzerland. Coordinate improvement projects and engage in corrective and preventive measures (CAPA)
* Build, verify and implement standard documents (SOPs)
* Joy in a human-centered and self-managed way of working based on NewWork, with a key focus to support the ongoing cultural and organizational change towards collaboration, agility and innovation mindset
Must Haves:
- Master Degree preferably in Life Sciences or Engineering or similar degree
* Min. 3 years of experience in the pharmaceutical industry in a quality manager role
* Experience in the area of pharmaceutical development such as packaging lines / materials, master data management, quality control or quality assurance is an advantage
* Knowledge of cGMP and quality requirements for clinical development phases
* Proven track record to work towards outcomes and an innovative manner of solving problems
* Strong team-player with a high level of self-motivation and being able to inspire others
* Ability to work in a purpose driven organization, taking full ownership for assigned roles and tasks, continuously willing to improve individual and team effectiveness
* Ability to communicate clearly and professionally verbally and in writing in BOTH German and in English
* Experience with SAP and Veeva is a plus
Reference Nr.: 923164TP
Role:Quality Manager within IMP Quality Clinical Packaging (m/f/d)
Industrie:Pharma
Workplace:Kaiseraugst
Pensum: 80-100%
Start: ASAP
Duration: 12++
Deadline: 22.01.2024
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: .
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.