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.
- 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
- 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
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.