Job Title: QA Intern, Documentation and Data Integrity
About the Job:
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
Main Responsibilities:
The Quality Systems (QS) sub-team is under the remit of the Site Quality Department and is responsible for the quality system management (QMS) implementation within the site. The QS sub-team is responsible for setting up or reviewing and auditing the quality management systems to be used by the entire site, which is instrumental in ensuring the site systems and processes meet the international GxP requirements.
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The Data Integrity Program is key to ensure the compliance use of the digital initiatives. This includes working closely with the respective functional teams to provide oversight and guidance for data integrity and projects related to data integrity to achieve the site's digital ambition while in compliance with data integrity requirements. Another aspect is to manage Quality Culture program, enabling the right Quality Culture to be embedded onsite.
About You:
New project for Documentation Management System:
- Support the implementation of digital documentation solutions like electronic logbooks and manage the GMP governance and issuance of paper-bound logbooks on site.
- Support the implementation of digital documentation solutions like electronic forms and manage the GMP governance and issuance of controlled printing of forms on site.
- Lead and implement framework and solution for document archival and destruction process on site.
- Set up site document archive room.
Quality Culture Program/ Data Integrity :
- Support in the development and roll out the Quality Culture program onsite
- Tracking of Quality gaps and near misses, with the use of data visualization tool to communicate stakeholders
- Status tracking of identified actions in Data Integrity Plan