Associate Specialist, Quality Assurance (Document Management)

Company Background

Tessa Therapeutics is a clinical-stage biotechnology company developing a portfolio of next-generation cell therapies for cancer. It has a pipeline of therapies in clinical development for the treatment of hematological malignancies and solid tumors.

Tessa’s lead autologous therapy is in late-stage clinical development for treatment of lymphomas. It has shown strong clinical responses in patients with relapsed/refractory classical Hodgkin lymphoma, based on which it was granted the RMAT designation by the U.S. FDA and the PRIME designation by EMA.

Tessa is also developing a novel, differentiated, allogeneic “off-the shelf” cell therapy platform to create more efficacious, reliable, and scalable therapies capable of targeting a broad range of cancers. A therapy using this platform is being evaluated in an ongoing clinical trial in United States.

Job Position
Associate Specialist, Quality Assurance (Document Management)

Job Description

  • Responsible for site documentation control activities which include site Electronic Document Management System (EDMS) and all other documentation activities as required
  • Responsible for document retention/ archival and storage. Ensure archived documents/ records are protected, maintained and accessible throughout the retention period.
  • Review and final approval of cGMP documents such as SOPs and logbooks.
  • Review of executed manufacturing batch records for completeness and compliance to cGMP requirements.
  • Responsible to develop procedures and workflow required to ensure a compliant and robust document management system.
  • Provide QA support for TrackWise records as assigned, and to ensure timely closure of these records.
  • Adhere to data integrity requirements for paper and electronic documentation.
  • Support improvement initiatives, programs and projects driven from the Quality Management System.
  • Escalates quality and compliance risks to QA Management.
  • Any other tasks as and when assigned by manager.

Requirements

  • Diploma in Life Science, Engineering or equivalent with preferably 1-2 years of relevant work experience.
  • ITE Certificate in Life Science, Engineering or equivalent with more than 5 years relevant working experience.
  • Good understanding of cGMP and GDP requirements.
  • Attention to detail
  • Good interpersonal and communication skills
  • Team player who is able to work independently and / or within team(s) with minimum guidance
  • Strong focus on safety, quality and deliverables