Quality Assurance Associate
hace 19 horas
Description
Title: Quality Assurance Associate Job Purpose: As a Quality Assurance Associate at Marken, you will be responsible for ensuring compliance with regional and local regulations, as well as customer requirements. You will oversee and implement the Marken Quality Management System (QMS), Standard Operating Procedures (SOPs), processes, and policies. Main Duties and Responsibilities:- Implement, communicate, and maintain company quality systems in compliance with Marken's Global QMS requirements.
- Interact with clients on Quality Assurance (QA)/GxP related matters under management supervision.
- Effectively interact with Marken Departments and stakeholders to ensure QA tasks are appropriately supported.
- Support internal audits.
- Support client audits and regulatory inspections.
- Responsible for the QTA process, including ownership of the QTA template and ensuring compliance with the SOP.
- Collate issues, CAPA, Risk Assessment, Change Control, and training metrics.
- Identify relevant GxP/Quality related training needs and deliver training where required.
- Ensure the Marken Quality System and GxP Program are implemented and maintained.
- Ensure the accuracy and quality of records and documents.
- Participate in internal Quality and designated meetings.
- Minimum 1 year of experience in a Quality Assurance role within a GSP/GMP/GDP/GCP regulated position.
- High or Secondary School diploma or equivalent with experience in relevant job-related skills.
- Related knowledge of Good Manufacturing Practice, Good Clinical Practice, Good Distribution Practice, and Good Storage Practice guidelines.
- Related knowledge of local regulations.
- Detailed oriented.
- Oral and written communication skills.
- Good interpersonal skills.
- Organized, methodical, and efficient approach to work.
- Proficient use of Microsoft Office.
- Fluent in English, Multilingual in Spanish and English preferred.
- Knowledge of Cold chain supplies and logistics, Storage, and distribution for pharmaceutical products preferred.
- Knowledge and understanding of GDP and ISO Compliance desired.
- Previous experience in Quality Management Systems preferred.
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