Senior Specialist Quality – Systems – Deviation and Change Control Management (m/f/d)

We are an owner-managed and globally active company in the area of Speciality-Pharma with a clear mission: to be the sustainable platform for long-term established and familiar pharmaceutical branded products of various therapeutic areas. As a reliable partner of the researching pharmaceutical industry, CHEPLAPHARM ensures the availability and supply of these drugs for the world market. This not only benefits our partners, but also patients: all over the world. With our specialized business model, we are proud to have developed into one of the world's leading companies in the acquisition of original products within 20 years and we continue to grow. The claim of our around 800 employees: Together „MEHR BEWIRKEN“. In our team Quality Assurance Systems, 18 colleagues work:inside and we control all the central QA processes – from deviation and CAPA management, change control and complaints to quality-relevant validations. With technical depth and strong system understanding, we ensure regulatory compliance and the effectiveness of our quality system. What makes us think is a high degree of professional expertise, system thinking and the common commitment to sustainable and future-oriented quality.

Deviation and Change Control Management Professional responsibility for deviation and CAPA management as well as for controlling change control procedures. The role of global process owner is to control and evaluate changes to processes and systems, including risk analyses, impact assessments and effectiveness tests. Continuous improvement Design and optimization of quality-relevant processes as well as creation of risk analyses, reviews, request documents and KPI reports. In addition, support in the visualization of the QM process landscape. Compliance Creation and maintenance of SOPs, process instructions and guidelines in the electronic QM system. Executing training and effectiveness tests as well as monitoring internal and external audits as audits or (co) auditors. As part of the technical project management coordination of interfaces, preparation of decision bases and address-oriented communication of project progress.

Academic background / vocational training + professional background Complete study in the pharmaceutical, scientific or technical field or comparable qualification. At least four years of professional experience in a GMP-regulated environment, ideally in quality assurance with a focus on deviation management, change control and possibly Advertising processing using an electronic QM system. Industrial & International Experience Experience in the GMP-regulated environment of the pharmaceutical industry – ideally in global and local organizational units – and safe handling of tasks in an international environment. Technical and language skills Used in handling digital QM systems and MS Office, combined with a pronounced system understanding. Very good knowledge of German and English are used safely and according to target groups in word and writing. Working and communication Structured, process-oriented and solution-focused operation combined with high self-responsibility. Competent communication across interfaces, preparation of complex facts ready for decision and act as a binding contact: within an interdisciplinary team.

Corporate culture & internationality Growing company with a diverse open working environment and employees from around 40 nations. Flexible working models & work-life balance Individually customizable work models, including the possibility of working out of the EU country for up to two months a year. Working time account with leisure compensation as well as 30 days holiday. Individual benefits & precautions Flexible use of Benefits budget, e.g. for increased occupational pensions, fitness and health services or grants to travel and catering costs. Benefits & supplementary benefits Access to the Corporate Benefits platform with discounts at hundreds of partner companies. Further development and team culture Internal and external training coordinated with personal goals as well as corporate and team events to strengthen cohesion and celebrate success together. .