IMP Quality Assurance Specialist clinical packaging
Posted on Jun 26, 2021 by ITech Consult
IMP Quality Assurance Specialist clinical packaging - GMP guidelines and regulations, English, German
For our client Roche Diagnostic based in Rotkreuz we are looking for a IMP Quality Assurance Specialist clinical packaging.
At Roche, we believe it's urgent to deliver medical solutions right now - even as we develop innovations for the future. We are passionate about improve patients' lives, and we are confident in both decision and action. And we believe that good business means a better world. That is why we come to work every single day. We commit ourselves to scientific rigour, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.
Who we are:
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.
Who you are:
The role as an IMP QA Specialist 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 have detailed knowledge of GMPs as well exceptional interpersonal, managerial and negotiating skills and if you additionally like to follow a clear rationale in decision making you should apply for this job.
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.
Areas of responsibility:
* 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 Master Batch Records (MBR)
* Review batch record of finished and semi-finished goods
* Manage actively Deviations, Complaints and GMP-Issues
* Actively engage in optimization activities and improvements within IMP Quality CP Switzerland.
* Coordinate improvement projects and engage in corrective and preventive measures (CAPA)
* Build, verify and implement standard documents (SOPs)
* Actively support the introduction of new packaging processes
* Participate in planning meetings to ensure a timely supply to patients
* Lead self-inspections and participation in external Audits und Health Authorities inspections
* A key focus for you will also be to support the ongoing cultural and organizational change towards collaboration, agility and innovation in mindset
Professional and technical requirements:
* BSc Degree in Pharmaceutical Engineering or Life Science
* 1-3 years' experience in the field of quality assurance or production, preferably in the areas of pharmaceutical packaging and/or pharmaceutical industry
* First knowledge of relevant GMP guidelines and regulations
* Ability to communicate clearly and professionally both verbally and in writing in English as well as in German
* a technical and process knowledge on topics such as packaging lines, packaging materials and master data management are beneficial
* Proven track record to work towards results, excellent planning and organizing skills as well as analytical capabilities and an innovative manner of solving problems
* Strong team-player with a high level of self-motivation and being able to inspire others
Reference no: 920411 AD
Role: IMP Quality Assurance Specialist clinical packaging
Industry: Pharmaceutical industry
Location: Rotkreuz, Switzerland
Start date: ASAP (latest start date: 01.10.2021)
Duration: 12 months contract, with possible extension
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.