Quality Compliance Manager
New
E
Eva PharmaPharmaceutical
Remote (Germany-based)Part-TimeManager
Salary not disclosed
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Job Details
- Experience
- 5-7 years
Requirements
- Degree in Pharmacy, Life Sciences, or a related scientific discipline.
- Minimum 5-7 years of experience in pharmaceutical or healthcare quality management systems.
- Experience as a Responsible Person for Wholesale Distribution under German Medicines Act (AMG §52a).
- Strong knowledge of GxP requirements, German pharmaceutical regulations, and EU compliance standards.
- Ability to manage multiple quality activities, and effectively interact with internal and external stakeholders.
Responsibilities
- Maintain and continuously improve the local Quality Management System (QMS).
- Manage quality documentation, including SOPs, forms, records, and periodic reviews.
- Coordinate employee training, qualification programs, and compliance records.
- Lead supplier, customer, and service provider qualification activities.
- Plan, conduct, and follow up on internal audits and quality assessments.
- Manage deviations, quality events, CAPAs, and process improvement initiatives.
- Oversee quality-related interfaces with manufacturers, external service providers, and batch release partners.
- Prepare for, coordinate, and support regulatory authority inspections while ensuring ongoing inspection readiness.
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