Document Control Specialist

Company Background

Tessa Therapeutics is a leading biotechnology company specializing in the research, clinical development, and commercialization of cancer immunotherapy treatments. We are a global leader in employing Virus-Specific T cells (VST) to treat cancer. We are currently conducting the world’s first US FDA-registered Phase III T cell therapy trial in NPC, or any cancer indication. We have multiple recruitment sites in the following countries: Singapore, Malaysia, Taiwan, Thailand, and the US. In addition, we have a robust pipeline of both pre-clinical and clinical treatments, targeting multiple cancer indications.

Our mission is to cure cancers and save lives with our innovative and widely accessible immunotherapies.

We are looking for highly motivated and enthusiastic individuals who are interested to be part of our Quality team.

 

Job Position
Document Controller / Specialist

Reports to
Quality Assurance Associate Director / Quality Director 

Job Description for Document Controller / Specialist

  • Manage all documentation, records issuance and archival processes.
  • Ensure the document management system is compliant to regulatory, quality, and company requirements.
  • Collaborates with different departments and manufacturing sites during document change procedures.
  • Responsible of revision, issuance, notification and tracking of controlled / effective documents (i.e., SOPs, material specification, logbooks, etc.) using a document control system.
  • Ensure the latest version of documents are made available to all appropriate users and obsolete documents are removed from distribution.
  • Maintains databases that tracks GMP documentation.
  • Manage the issuance of Batch Manufacturing Records.
  • Ensures completeness (i.e. in accordance to Company requirements) and no grammatical error on revised documents during document review.
  • Responsible to train new staff and develop training content for document management system and procedures
  • Support research questions from various departments and manufacturing sites by using the document management tool. E.g. Provide reports as needed for different QMS performance metrics
  • Support audits (internal, external)
  • Responsible to maintain physical documents- e.g. Oversee document storage / filing areas.
  • Ensure periodic reviews for all GMP documents
  • Issuance of unique document numbers to the manufacturing sites. E.g. Batch Manufacturing Record Numbers, Validation protocol/report numbers, Qualification protocol/report numbers
  • Perform other duties as required.

Requirements

  • Degree in a science discipline with at least 3 years of hands-on experience in the pharmaceutical industry
  • Good knowledge of cGMP requirements
  • Working knowledge of quality systems
  • Able to identify problems, troubleshoot and complete or coordinate corrective actions.
  • Possess good people management skills.
  • Strong planning and prioritization of activities for self and team without supervision.
  • Ability to communicate (both orally and written) effectively in professional manner with peers and management.
  • High attention to details, well organised and effectively manage multiple projects.