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  • Location

    Netherlands

  • Job title:

    Quality Engineer | Packaging Documentation

  • Sector:

  • Job ref:

    45376

  • Start Date:

    2020-11-27

Packaging Process Documentation & Qualification Specialist

The Company
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.

Responsibilities
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

Requirements

- 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
 

Contact Us

SIRE LIFE SCIENCES B.V.

Staten Bolwerk 1
2011 MK Haarlem
The Netherlands
+31 (0) 20 658 9800

SIRE STAFFING SOLUTIONS B.V.

Keizersgracht 440A
1016 GD Amsterdam
+31 (0) 20 658 9804

SIRE LIFE SCIENCES DEUTSCHLAND GmbH

Theatinerstraße 11
80333 München
+49 (0) 89 3803 8966

SINCERE. INTELLIGENT. RESULT-DRIVEN. EXCELLENCE.