QA Manager for QMS / Documentation / Training / Software Validation (m/w/d)

Queisser Pharma develops, produces and sells, as a successful medium­size enterprise with an international 800 employees, free-market pharmaceuticals, food supplements and medical products. Our brands Doppelherz and Protefix take leading positions in their respective markets and are distributed to end users in Germany and abroad via pharmacies, drugstore and consumer markets and e-commerce. The foreign share is 40%. Inland, the brands Stozzon, Litozin and Tiger Balm are also distributed.

QA Manager for QMS / Documentation / Training / Software Validation (m/w/d)

Introduction (including computer system validation) and active cooperation in the care, development and monitoring of our electronic quality management system (deviations / CAPA / change control modules) as well as the document and training management system Takeover of the function of the operating system administrator for the electronic document and QM system: e.g. user management, testing and release of documents, KPI evaluations Exchange, distribution and training of documents Creation and updating of GMP-relevant documents, in particular SOPs, work instructions, plans, reports and templates Planning, coordination and follow-up of training measures Creation and maintenance of databases on specific issues and quality parameters Coordination and evaluation of amendments and deviation reports including deeper cause clarification and CAPAs (above and with product reference) Implementation and support of further validation projects Support in the preparation, coordination, implementation and follow-up of self-inspections, supplier audits, certification audits and authority inspections Support in the implementation of monitoring (including hygiene and media) / calibration/qualification and validation activities as well as the evaluation and evaluation of corresponding data

Successfully completed scientific studies or comparable qualification At least 2 years of professional experience as QA manager in QM / QS of the pharmaceutical and/or medical devices industry knowledge of current QM standards (e.g. GMP); ISO 13485 Impressed quality awareness and a structured, independent and solution-oriented way of working Safe handling of new software modules and technology affinity, SAP skills are advantageous Very good knowledge of German and English in word and writing as well as safe handling of Microsoft Office products We value personal qualities such as team skills, communication, joy of use, interdisciplinary thinking.

Benefits that we can offer you include flexible working hours, 30 days vacation, a canteen, freely available drinks and fruits, a gym and a grant to the job ticket. In addition, we offer you an occupational pension scheme, support for continuing vocational training and a child care facility through cooperation with a local day care facility. JOBV1_EN