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Job Description:
The Quality Support Center (QSC) Specialist supports the performance and activities within the QSC. He/She assist their management team to communicates the quality policy and objectives are implemented and maintained in alignment with healthcare guidelines (e.g., cGMP, GDP, GMP) and ISO 9001/ISO 13485 requirements. He/She supports the development standard operating procedures (SOPs), reviews and approves work instructions related to their area of responsibility, trains personnel and internal clients on SOPs and regulatory topics. This role supports activities withing the QSC, assesses trends, and communicate recommendations to the next level of management.
UPS Healthcare is looking for:
Main Responsibilities:
- Building and maintaining good and effective relationships with other departments within the company, including internal clients.
- Coordinating the change control process for both local and global changes.
- Handling deviations and customer complaints.
- Conducting quality risk assessments.
- Developing standard operating procedures and work instructions.
- Collaborating on reviews of policies, procedures, regulations, and specific work instructions.
- Conducting training within the area of expertise.
- Monitoring action plans and reporting delayed action plans to the next management level.
- Providing data and support for quality management system reviews within the area of responsibility.
- Reporting and evaluating data from the electronic quality management system.
- Supporting internal and regulatory audits within the area of expertise.
- Identifying areas for improvement and communicating recommendations to the supervisor.
- Participating in regular performance management meetings to support the high efficiency of the Quality Support Center.
Candidate Requirements:
- Bachelor's degree in a scientific or natural sciences field.
- Fluent English proficiency in both spoken and written communication.
- Experience with Microsoft Office applications (Excel, Word, Outlook, PowerPoint).
Preferred Qualifications:
- Experience working with GDP, GMP, ISO 9001, and ISO 13485 regulations.
- Experience in deviation management and change control.
- Experience in warehousing and distribution processes.
- Experience working with an electronic quality management system.
- Attention to detail and adherence to quality standards.
- Ability to identify potential process gaps and propose possible improvements
- Strong organizational skills and ability to meet deadlines.
- Skills in Power Query, DAX, VBA and Power BI.
- Proficiency in Spanish (spoken and written).
- Flexibility in working hours – the role may require work outside of the 09:00-17:00 schedule.
We offer:
- Subsidies for sports activities.
- Hybrid work mode (1 day HO per week) + 24 days of occasional remote work per year.
- Private medical care.
- Life insurance.
- Benefits from the Company Social Benefits Fund.
- Employee Pension Plan (PPE).
- Work in an international company with a stable market position.
- Opportunities for professional development and self-fulfillment - internal promotion policy.
Please send your CV in English.
Before proceeding with the recruitment process, please familiarize yourself with the procedure at the following link: https://ups.pagetiger.com/bdpxpfu
Employee Type:
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