IMP Quality Clinical Packaging

IMP Quality Clinical Packaging - quality manager / cGMP / clinical development phases / packaging lines or materials, master data management, quality control or quality assurance /German/ English

Project / Role:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified 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..

Main Tasks:
• 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:
• Min. 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
• Knowledge of cGMP and quality requirements for clinical development phases
• Experience in the area of pharmaceutical development such as packaging lines or materials, master data management, quality control or quality assurance is an advantage
• 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 is a must.
• Experience with SAP and Veeva is a plus

Reference No.: 924209SDA
Role: IMP Quality Clinical Packaging
Industry: Pharmaceutical
Location: Kaiseraugst
Workload: 100% (Min. 80% onsite)
Start: ASAP
Duration: 12++

Should you find yourself suitable for this position, please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert or to jobs[at]itcag[dot]com.

Contact us for further information regarding our company, our positions or our attractive payroll-only-program: +41 41 760 77 01.

About us:
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. Specializing in delivering IT candidates for contract work, we understand the importance of professional support in your search for a new project. Established in 1997 by IT professionals, we are committed to your success.