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Quality Assurance Manager
vor 2 Monaten
As a key member of the 44 Clinical team, we are seeking a highly skilled Quality Assurance Manager to lead our Quality Management System (QMS) efforts. This role involves overseeing QA processes, documentation, and supervising the QA team under your leadership.
Main Responsibilities:- Lead, support, and mentor QA team members under direct supervision.
- Implement defined quality objectives for assigned QMS areas.
- Distribute, structure, and monitor quality tasks related to QMS areas.
- Assist in daily QA department and QMS tasks.
- Participate in customer meetings to discuss metrics or QMS aspects.
- Coordinate and assist with GMP internal audits and external audits (e.g., vendors).
- Support customer and regulatory audits, and associated actions.
- Act as a quality representative in cross-departmental meetings.
- Manage and improve assigned QMS areas.
Key responsibilities also include leading and supporting QMS aspects related to change management, investigations, deviations, CAPAs, risk assessments, validation, recalls, and quality metrics. Additionally, you will provide training for quality and relevant personnel and support strategic quality-related projects.
Requirements:- ~5 years of experience in a quality systems role, ideally pharma-related.
- ~2-3 years of experience leading teams, including disciplinary processes.
- ~ Experience in Quality departments, preferably in a packaging or pharmaceutical company.
- ~ Knowledge of packaging equipment, facilities, and processes.
- ~ Strong understanding of Quality Assurance inspection requirements.
- ~ Experience with risk analysis methodologies.
- ~ Formal training in GMP requirements from Quality Assurance.
- ~ Fluency in business English and German.
