Helaxa is a company in Luckenwalde founded in 2022 by Erol Isim and the traditional family business HELM AG and specialises in the production of the life-saving active ingredient heparin. On a total area of 22,500 square metres, the most modern and efficient production facility in Europe is being built, which will meet the highest quality standards.We are looking forQuality Assurance Manager (m/f/d)Date: Dec 19, 2024Location:Luckenwalde, DE, 14943Business Unit: Helaxa GmbH & Co KGJob Function: Quality Management / HSELevel of Experience: Executive"Caring today. Enabling tomorrow" is more than just a slogan for us. It is the daily inspiration for collaboration, as well as all our actions and decisions. This describes the philosophy of Helaxa, a newly established company in Luckenwalde dedicated to manufacturing active ingredients for life‑saving medicine. For our dynamic and growing company in Luckenwalde, we are seeking for dedicated talents (m/f/d) who are motivated to drive our mission ‘Caring today. Enabling tomorrow' with passion.Position ObjectiveParticipation and independent fulfillment of tasks in quality assurance according to AMWHV / EU‑GMP guidelinesResponsibilitiesImplementation of requirements formulated in relevant EU regulations for quality managementHandling tasks to maintain and monitor the pharmaceutical quality management systemPromoting quality awareness within the companyParticipation in document control by creating or reviewing quality‑relevant documentsProcessing deviations and changesParticipation in training managementParticipation and support in conducting customer audits and regulatory inspectionsParticipation in the investigation and resolution of quality‑related complaintsCollaboration in overarching, cross‑departmental projects, as neededInterface communication with other departmentYour ProfileSuccessfully completed university studies in pharmacy, veterinary medicine, natural sciences, or similarSeveral years of relevant work experience in quality assurance, production, or quality control of a GxP‑regulated pharmaceutical company or a similarly regulated company (e.g., medical device manufacturer)Solid experience in quality management systems (e.g., EU‑GxP, DIN ISO standards 9001 or 13485)Strong technical understanding of pharmaceutical processes and business processesOrganizational and communication skills, as well as a sense of responsibilityStructured and goal‑oriented actionHands‑on mentality with a high level of initiativeStrong communication skills and assertivenessVery good German and English language skills in speech and writingGood computer skills"A new player. A new culture. A new game." Each individual contributes to the success of Helaxa daily through responsible actions, extensive expertise, and unique service. We value this commitment, not only by offering development opportunities and internal/external training but also by providing benefits that create optimal conditions for a work‑life balance. We look forward to meeting you.Does this sound like you?Then we look forward to receiving your detailed application via our application portal. #J-18808-Ljbffr