Manufacturing Quality Assurance (MQA) Manager

Hely: Budapest
Cég: XELLIA Gyógyszervegyészeti Kft.
Kategória: Egészségügy, Gyógyszeripar

Lead QA oversight for all manufacturing operations.Ensure compliance with relevant legislation, GxP regulations and guidelines.Make release decisions for APIs, intermediates, raw materials and packaging materials.Handling deviations, CAPAs, change controls, OOS investigations, complaints and recall.Approve CoAs, specifications, stability protocols, validation and other relevant documentation.Support cGMP inspection readiness and participate in audits/inspections.Drive continuous improvement across QA processes.Lead, mentor and develop the MQA Specialist team.Act as GDP responsible person from quality point of view.Collaborate with Operations, RA, Logistics, Business Operations, Supply Chain and other stakeholders. MSc degree in Chemistry, Biology, Pharmaceutical Sciences, or another relevant Life Sciences discipline.Advanced scientific education, specialization in pharmaceutical-related fields is an advantage.Sterile manufacturing experience could be an advantage.Minimum 5 years of experience in the pharmaceutical industry in Quality Assurance, Quality Control, Manufacturing, or a related function.At least 3 years of proven people leadership experience.Strong knowledge of pharmaceutical quality systems and a quality-first mindset.Ability to lead teams, set priorities, make sound decisions, and deliver results within agreed timelines.Proactive, decisive, and capable of managing complex quality and compliance challenges.Excellent communication and stakeholder management skills, with the ability to collaborate effectively across functions.Comfortable working in a dynamic, international environment.Fluent English (written and spoken). Competitive compensation and benefit package„Nordic-style” culture – dynamic teamwork, good working atmosphere, flexibility, maintaining work-life balanceOpportunity to learn and developGood team spirit and friendly colleaguesStable international company backgroundMultinational working environmentHome Office opportunity

Címkék: Employee status, College

profession.hu - 7 napja

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