Hays AG

Stellenangebot: Validierungsexperte in der Qualitätssicherung (m/f/d)

Mannheim Vollzeit

Jetzt bewerben

Über uns

With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.

Ihre Aufgaben

Document authoring and review as required to support changes. Performs technical reviews, as applicable. May require collaboration with supervisor on technically complex technical reviews independently
Preparing documentation for and participating in audits as applicable
Responsible for training, coaching and mentoring other quality managers or business partners, as applicable in a professional manner to ensure that business needs are being met
Able to troubleshoot issues as they arise, develop and independently implement solutions to ensure that daily work is completed without jeopardizing compliance
Communicating significant quality or regulatory issues and risks that may impact product quality or regulatory compliance in a timely manner to Executive Management
Complete daily scheduled and unscheduled activities, initiate activities independently and interactions across departments as applicable
Identify, Initiate, facilitate, participate and implement process improvements to meet business needs. Able to link responsibilities with both site and Global Quality and Regulatory and drive innovation across the local organization/site
Participates in large/global cross-functional or cross-chapter projects
Be involved in solving unique or unprecedented problems that have an impact on a part of the organization, function or chapter
Build and maintain strong partnerships with colleagues and business patterns to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships

Ihr Profil

Completed Master's degree in natural sciences e.g. chemistry, biotechnology or pharmacy, alternatively a completed Bachelor's degree in natural sciences with professional experience in a comparable field
Profound work experience in the GMP environment, ideally in quality assurance and quality control in dia- and/or pharmaceutical sector
Profound knowledge of analytical and method development/validation as well as process and method transfer
Profound knowledge of cleaning processes
Experience in the preparation of process risk analyses and good process understanding
Ensure implementation of regulatory requirements and review of above validation documents and inspection and test plans
Experience in the creation or evaluation of process risk analyses
Knowledge of deviation management and change control
Profound knowledge of MS Office and Google applications e.g. G Suite
Ability to work in a team and experience in agile working