IMP Quality Assurance Specialist (m/f/d)

IMP Quality Assurance Specialist (m/f/d) – Pharma / GMP / Master Data / English / German

Project:
For our customer a big pharmaceutical company situated in Kaiseraugst we are searching for a highly qualified IMP Quality Assurance Specialist (m/w/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 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[1]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.

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 of manufacturing specifications and Batch Records (BR)
– Review batch record of finished and semi-finished goods
– Manage actively Deviations, 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
– A key focus for you will also be to support the ongoing cultural and organizational change towards collaboration, agility and innovation in mindset.

Must haves:
– BSc Degree in Pharmaceutical Engineering/Life Science AND / OR professional experience in the field of quality assurance or production, preferably in the areas of pharmaceutical packaging and / or pharmaceutical industry*
– Detailed knowledge of relevant GMP guidelines and regulations
– 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
– Ability to communicate clearly and professionally both verbally and in writing in English as well as in German

(* The Department is also open for ’starters‘ in this Quality Operations area, provided they bring the right educational background in Life Sciences or Engineering)

Referenz Nr.: 921332SKN
Role: IMP Quality Assurance Specialist
Industry: Pharma
Location: Kaiseraugst
Workload: 80-100%
Start: 16.05.2022
Duration: 1 year, with possible extension
Deadline: 06.04.2022

Should you find yourself suitable for this position then 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. ITech Consult is specialised in delivering IT and Life Science 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.