Quality Assurance Manager
vor 3 Wochen
At 44 Clinical, we are seeking a highly skilled Claims Quality Assurance Officer to join our team. As a key member of our Quality Assurance department, you will be responsible for leading specific sections of our Quality Management System (QMS) and handling day-to-day Quality Assurance (QA) responsibilities.
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.
- Lead and support QMS aspects related to change management, investigations, deviations, CAPAs, risk assessments, validation, recalls, and quality metrics.
- Provide training for quality and relevant personnel.
- Support strategic quality-related projects.
- ~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.
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