Documentation Specialist (QA)
Location: Qu?n 3, VietnamThe company
Our client is a biopharmaceutical company engaged in the development of cancer immunotherapies with the aim to provide long-term responses and eliminate this chronic disease.
About the role
As a QA Documentation Specialist, you will be in charge of the issuance of batch documents and label packages, including final product labels per cGMP; ensure the accuracy and completeness of the QA documents and support audits.
Responsibilities
- Issue batch documents, label packages and logbooks
- Be in charge of the timely consumption of consumables and/or GMP materials used
- Ensure that the issued documents are correct
- Identify and investigate compliance gaps
- Participate in internal and external audits
Requirements
- More than 2 years of experience with documentation in a highly regulated environment
- Advanced knowledge of GMP
- Ability to explain the document creation procedures and guidelines to external parties
- Advanced English level
Other information
Are you interested and do you want to apply for this role, please fill out your application via the apply button below and contact Camila Castro.
