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Tätigkeitsbeschreibung:
The Healthcare Quality Assurance Supervisor is responsible for the oversight and implementation of the Marken Quality Management System (QMS), Marken Standard Operating Procedures (SOPs), processes and policies required to manage and control Marken’s Storage, Distribution and Transportation, Kit Production Facility, as applicable. The Healthcare QA Supervisor also need to ensure compliance with applicable regional and local regulations and requirements, and customer requirements as appropriate, but not limited to current Good Manufacturing Practice (GMP), Good Distribution Practices (GDP), Good Storage Practices (GSP), ISO 13485 and ISO 9001.
Main Duties and Responsibilities
1. Implement, communicate and maintain Company’s quality systems and policies at the facility, in compliance with Marken’s Global quality management system requirements and local requirements.
2. Effectively interact with other Marken departments and stakeholders to maintain quality and help introduce new quality improvements.
3. Agree standards and define quality processes and procedures through effective controlled document issue and management.
4. Interact with clients on Quality Assurance (QA)/ GxP related matters.
5. Write quality assurance procedures as required for GxP Compliance.
6. Participate and monitor the internal audit schedule and perform/ or delegate, including report preparation, assessment and tracking of associated corrective and preventive actions (CAPA). To ensure that a self-inspection audit is done once a year in the local Marken facilities.
7. To maintain the vendor qualification program, this includes, but it is not limited to the QTA (Quality Technical Agreements) updates and performing Quality audits.
8. Host client audits and regulatory inspections, manage the audit report responses and act as Marken’s main representative, including and prepare appropriate materials required within those audits when applicable.
9. Manage issues and CAPA plans, collate CAPA metrics, and identify and implement quality improvement initiatives.
10. Identify relevant GxP/Quality related training needs and deliver or make they are deliver where required.
11. Maintain the oversight of review and release of incoming material receipts in accordance with product specification where applicable.
12. Perform QA role in qualification/validation activities.
13. Manage/Approve the change control.
14. Co-ordinate any product recall as required and ensure that a mock recall is carried out on an annual basis where applicable.
15. Prepare and acquire appropriate data to complete trending and KPI reporting requirements.
16. Keep informed of regulatory changes in Country/Region and prompt updates to SOPs as needed.
General duties
1. Ensure compliance with national and international standards and legislation
2. Ensure timely and efficient management of records pertaining to the Quality Assurance Team.
3. Travel as reasonably requested by the Line Manager for the performance of duties.
4. Undertake any other reasonable duties at the request of the QA Management.
5. To manage and support their QA Associate in daily activities.
Who You Are
What you’ll need (Essential Criteria):
Experience: You bring 5+ years of relevant experience working in a Quality Assurance role within a GSP/GMP/GDP regulated position.
Education: You hold a Bachelor of Science and/or a similar university degree.
Industry Knowledge: You possess comprehensive knowledge of Good Manufacturing Practice (GMP), Good Storage Practice (GSP), and Good Distribution Practice (GDP) guidelines, alongside a strong grasp of local regulations.
Technical QA Skills: You have a proven track record working with Quality Management Systems (QMS) and a sharp eye for detail.
Tools & Communication: You are fluent in English with excellent written and oral communication skills, strong interpersonal abilities, and proficiency in Microsoft Office.
Work Style: You are highly organised, methodical, and bring an efficient approach to your daily workload.
Bonus points if you have (Desirable Criteria):
Specialised Logistics: Knowledge of cold chain supplies, logistics, storage, and distribution of pharmaceutical products.
Compliance & Auditing: Deep understanding of GDP and ISO compliance, being Six Sigma certified, or holding a Certified Lead Auditor designation.
Leadership: Previous experience in a managerial position with direct staff reporting to you.
Global Mindset: Multilingual skills and cross-functional experience tailored for international assignments.
Art der Anstellung:
Unbefristet
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