Quality Assurance Manager
Vor 3 Tagen
As a Quality Assurance Manager at Randstad, you will be responsible for supporting quality activities in LATAM and MMG operational areas, acting as the Responsible Person for LATAM GmbH and Medical GmbH. You will execute Quality Management system activities on behalf of IACs to ensure compliance with GxP legislation.
Key Responsibilities:
- Support Quality activities in LATAM and MMG operational areas, acting as the Responsible Person for LATAM GmbH and Medical GmbH.
- Execute Quality Management system activities on behalf of IACs to ensure compliance with GxP legislation.
- Provide oversight of Quality Assurance activities for third-party manufacturers, packaging operations, and other outsourced entities in Consumer Health and Ethical areas.
- Conduct Supplier Assurance activities to maintain the qualification status of raw material and packaging suppliers.
- Offer Quality advice and support to internal and external stakeholders.
- Implement and maintain a Quality Management System, complying with relevant regulations.
- Act as the Responsible Person for LATAM GmbH and Medical GmbH, and as Deputy Responsible Person for MLG, MAG, MNE MEA, and MMCO.
Additional Responsibilities:
- Lead Basel Quality Management System activities, including Complaints, Change Control, Recall, Audits, Self-Inspections, and Training.
- Lead 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 regular reports to upper Management.
- Assist Independent Associated Companies with Quality-related topics.
- Escalate significant Quality issues to superiors.
- Serve as a local expert for GxP-related questions.
- Manage Third-Party providers by updating agreements, conducting Quality Review Meetings, ensuring regulatory documentation, and reviewing stability data.
- Review third-party Change Control, Deviations, CAPA, and Complaints using risk management principles.
- Participate collaboratively with internal and external stakeholders to resolve issues and ensure product quality, compliance, and supply.
- Establish effective partnerships and relationships with third parties.
Requirements:
- Degree in natural science (Chemistry, Pharmacy, Biology, etc.) or higher.
- Minimum 5 years of QA experience, preferably in a managerial role in the pharmaceutical industry.
- Experience in Quality Supplier Management.
- Excellent knowledge of GMP and GDP regulations for drugs, devices, cosmetics, etc.
- Fluent in spoken and written English & German.
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