QA Manager
vor 1 Woche
- To carry out Quality Management system activities on behalf of IACS to ensure compliance to current GxP legislation
- Provide management, leadership and oversight of Quality Assurance activities for, third party contract manufacturers, packaging operations and other outsourced third parties as relevant (Consumer Health and Ethical area).
- To carry out Supplier Assurance activities on behalf of relevant IACs to ensure Qualification status of raw material and packaging suppliers are maintained.
- Provide Quality advice and support to our internal and external customers.
- Provide support for implementing and maintaining a Quality Management System (QMS) at Mundipharma Basel which complies with applicable parts of the following regulations (not limited to):
- Swiss "AMBV Art.12-14"
- EU "Good Distribution Practices (GDP)"
- Acting as a Responsible Person (German: Fachtechnisch Verantwortliche Person) for Mundipharma LATAM.
- Acting as a Deputy Responsible Person (German: Fachtechnisch Verantwortliche Person) for MMG, MLG, MAG, MNE and MEA.
Management Systems (e.g., Complaints, Change Control, Recalls, Audits, Self-Inspections, Training etc.)
- Perform and lead adequate Supplier, Customer and Service provider qualification activities including audits.
- Implement and update Technical Quality Agreements with Suppliers and Customers
- Support and lead Quality Management Reviews and other regular reports to the upper Management
- Support Independent Associated Companies regarding Quality related topics
- Escalation of significant Quality issues to the superior.
- Act as local expert for GxP related questions.
- Management of Third-Party providers by:
- Updating Technical/Supplier agreements
- Writing new Technical/Supplier agreements
- Conducting effective Quality Review Meetings
- Ensuring all regulatory required documentation is in place
- Reviewing Periodic Quality Reviews
- Reviewing of Stability data
- Review of thirdparty Change Control, Deviations, CAPA and Complaints using risk management principles
- Review and generation of Supply Chain Maps
- Participate and work collaboratively with internal and external stakeholders on issue resolution to ensure product quality, compliance, and supply.
- Establish effective partnership and relationship with third parties
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