Sartorius is Hiring Documentation Specialist Validation Services

Job Description :

As part of your job, you will assist with the documentation of Confidence Validation Services (single-use parts like filters) in accordance with the technical specifications provided by the project management team in order to satisfy legal and client requirements. creation and upkeep of systems for periodically monitoring documentation workflow and processes. Maintaining current workflow procedures and documentation standards through database updates and cooperation with the project management team. The Sartorius With an emphasis on filter and single-use application validation, Confidence® Validation Services offers services to clients in the (bio)pharmaceutical sector.

Responsibilities :

English-language creation and evaluation of scientific and technical validation documents, such as reports, procedures, and statements, among others

Technical details in the validation documentation should be coordinated as soon as possible with the project management team and other internal stakeholders, as needed.

Independently compile data from subject matter experts and the project management team in order to arrange and draft validation papers.

When needed, optimize the documentation flows and validation document templates

 Create and keep up comprehensive databases with pertinent reference information.

Assess the content that is already available and assist in the creation of methods for improvement.

Create and manage tracking systems with the use of relevant technologies, and submit a monthly summary report.

Requirements :

Masters degree in biotechnology, microbiology, chemistry or equivalent.

Minimum 3-5 years’ experience in life science industry

Prior experience creating procedural materials and documentation for various audiences.

Understanding the principles of microbiology is a plus.

It is advantageous to have knowledge of filtration, extractables, leachables, and related analytical techniques including GC-MS, LC-MS, and HPLC-UV.

Gaining knowledge of pharmaceutical industry regulations (FDA, EMA, WHO, etc.) and medication manufacturing procedures is advantageous.

Knowledgeable about GDP and GMP (Good Documentation Practices) concepts Working in international environments before is advantageous.

Outstanding oral and written English communication abilities with a keen attention to detail.

Exceptional proficiency with Word, Excel, and PowerPoint in the Microsoft Office suite.