Document Quality Specialist

☞ PharmiWeb.jobs: Global Life Science Jobs

View: 158

Update day: 29-03-2024

Location: Basel Basel-Stadt BS

Category: Quality Assurance / Quality Control

Industry: Staffing Recruiting

Position: Entry level

Job type: Full-time

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Job content

Achieva are currently recruiting for an experienced Document Quality Specialist to join a leading pharmaceutical company based in Basel.The ideal candidate will be someone with experience within a similar position, hold a degree in a scientific discipline or equivalent and be able to work successfully within a matrix environment.Job Responsibilites
  • Perform source data verification (SDV) and technical (Novstyle) quality control (QC) of NIBR submission documents (simple to medium complexity) to ensure both content and format fulfil requirements. Collaborate with globally located NIBR scientific personnel to ensure finalisation of the documents, according to timelines and quality requirements.
  • Compile, integrate and publish applicable NIBR documents with state-of-the-art word processing, electronic publishing and document management systems in collaboration with the responsible author(s).
  • Work with external consultants (vendors) to coordinate outsourced QC activities related to the processed tasks. Responsible for verifying and consolidating the QC recommendations from the external consultants and partner with the respective document author(s) to reconcile findings and finalise the submission document(s).
  • Resolve technical document or work flow issues as applicable on the documents being processed.
  • Advise authors, newcomers and vendors on SDV requirements, technical formatting processes and the use of Novartis’ document management systems.
  • Remain abreast of current processes, regulatory guidelines and legal requirements, as relevant.
  • Collaborate with Submissions Management team on specialised projects, to support key submission deliverable.
  • Collaborate to provide metrics, KQIs and KPIs
RequirementsEducation (minimum/desirable): Undergraduate degree preferably in a scientific discipline or equivalent work experienceLanguages: English fluent (oral and written)Experience/Professional Requirement
  • Relevant work experience with electronic document management systems and document review.
  • Basic understanding of clinical and nonclinical information contained in a submission dossier.
  • Flexible and detail oriented approach to documentation management, as appropriate.
  • Experience with and ability to understand compliance practices, which include GxPs and Standard Operating Procedures.
  • Strong oral and written communication skills and customer service mindset.
  • Proficient in Microsoft office programs (e.g. MS Word).
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Deadline: 13-05-2024

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