Quality Assurance Specialist

UPS Supply Chain Solutions, Inc.; Brasil; On-site; BRL 90,000 - 150,000; Full time

Job summary

UPS Supply Chain Solutions, Inc. in Brazil is seeking a Quality Assurance Specialist to support the QA Supervisor with overseeing the Marken QMS, SOPs, and distribution and storage activities.

The role emphasizes compliance with GMP, GDP, GSP, ISO 13485 and ISO 9001, and coordinating QA tasks with cross-functional teams. You will manage internal audits, CAPA processes, vendor audits, client audits, and regulatory inspections, while ensuring accurate records, training, change control, and timely

Qualifications

• Pharmaceutical or healthcare industry experience.
• Bachelor’s Degree in Science related field (or internationally comparable degree) required.
• Knowledge of GMP, GDP and GSP guidelines.
• Knowledge of local regulations.
• Experience with Quality Management Systems and attention to detail.
• Excellent written and oral communication skills.
• Proficient use of Microsoft Office.
• Advanced English communication.

Responsibilities

• Implement and maintain the Marken quality systems at the facility.
• Interact with clients on QA/GxP matters.
• Coordinate internal audits and CAPA tracking and reporting.
• Audit external vendors as part of supplier qualification and monitor actions.
• Support client audits and regulatory inspections and respond to audit reports.
• Manage CAPA plans and drive quality improvements.
• Ensure records and documents are accurate and training is tracked.
• Coordinate recalls when necessary.
• Stay informed of regulatory changes and update SOPs accordingly.

Skills

Pharmaceutical or healthcare industry

Excellent written and oral comms

Organized, methodical and efficient

Advanced English communication

Education

Bachelor’s Degree in Science related field

Tools

Microsoft Office

Job description

Before you apply to a job, select your language preference from the options available at the top right of this page.

Explore your next opportunity at a Fortune Global 500 organization. Envision innovative possibilities, experience our rewarding culture, and work with talented teams that help you become better every day. We know what it takes to lead UPS into tomorrow—people with a unique combination of skill + passion. If you have the qualities and drive to lead yourself or teams, there are roles ready to cultivate your skills and take you to the next level.

Job Description:

Job Summary

The Quality Assurance Specialist is responsible for supporting the QA Supervisor with the oversight and implementation of the Marken Quality Management System (QMS), Standard Operating Procedures (SOPs), processes and policies required to manage and control Marken’s Storage, Distribution and Transportation, Kit Production Facility.

The QAS also needs 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.

Responsibilities:

• Implement, communicate and maintain the company’s quality systems at the facility, in compliance with Marken’s Global Quality Management System (QMS) requirements.
• Interact with clients on Quality Assurance (QA)/ GxP related matters.
• Effectively interact with Departments and stakeholders to maintain that all QA tasks are appropriately supported by QA.
• Oversee an internal audit schedule and perform internal audits including report preparation and assessment and tracking of associated corrective and preventive actions (CAPA).
• Perform audits of external service providers as part of the vendor selection process. Tracking and overseeing all commitments for actions or changes made from previous audits.
• Support client audits and regulatory inspections, including and preparing appropriate materials required within those audits when applicable. Support the audit report responses and act as main representative when aligned with QA Supervisor.
• Work and manage issues and CAPA plans, collate CAPA metrics, and identify and implement quality improvement initiatives.Oversee activities that conclude on the appropriate close-out of all CAPA entries.
• Identify relevant GxP/ Quality related training needs and deliver or ensure they will be delivered when required.
• Support on change control management.
• Ensuring that the Quality System and GxP Program are implemented and maintained.
• Assisting in the evaluation of designated vendors and/or out-sourced activities.
• Ensuring the accuracy and quality of records and documents.
• Monitor that training for all personnel is conducted and documented.
• Coordinating and promptly performing any recall activity.
• Participate actively in all the internal Quality and/ or designated meetings.
• Keep informed of regulatory changes in Country/Region and prompt updates to SOPs as needed.
• To execute qualification activities and oversee calibration related to devices, equipment, systems and facility in SAO branches.
• Ensure that the facility is working according to local laws and authority regulations

Qualifications:

• Pharmaceutical or healthcare industry experience;
• Bachelor’s Degree in Science related field (or internationally comparable degree) required;
• Knowledge of Good Manufacturing Practice, Good Sorage Practice and Good Distribution Practice guidelines;
• Knowledge of local regulations;
• Previous experience in Quality Management Systems with an eye for details;
• Excellent written and oral communication skills;
• Good interpersonal skills;
• Organized, methodical and efficient approach to work;
• Proficient use of Microsoft office;
• Advanced English communication;

Employee Type:

Permanent

UPS is committed to providing a workplace free of discrimination, harassment, and retaliation.