Packaging Process Documentation & Qualification Specialist
The company has a Biotech and Pharmaceutical operations site. They are one of the biggest innovative companies in the Netherlands and they are specialized in vaccines, biological therapies and medicines.
Within this Packaging Simplification & Sustainability project the Specialist will be responsible for defining and documentation of the processes used to select, implement and qualify the correct packaging materials, for new and for changed packaging components. In more detail following activities are included:
1. Write procedures (SOP). Write procedures for standard processes.
2. Creation and maintenance of templates Create (approved) templates for different documents and maintain these in controlled documentation system (Midas).
3. Maintenance of Global packaging component specifications Perform updates to global PCS Write new global PCS Transfer global PCS to sites
4. SAP and AERA data extraction Support global PTS team when information from SAP and AERA is required.
5. Support qualification testing and line trials performed by global PTS Implementation qualification support for the new packaging materials, setup of the standard documents for qualification and execution: Create protocols / Order samples
- Bachelor or Master degree (HLO / Life Sciences / Process Technology
- Familiar with pharmaceutical- or process SOPs
- Experience in writing technical documents
- Scientific writing
- Strong MS Office skills