Quality Services Officer
||Voltijd (> 36 uur)
||maandag 7 mei 2018
||maandag 4 juni 2018
Do you have a BSc/HLO chemistry background and pharmaceutical laboratory experience and do want to work within a quality role? Our client in the Amsterdam area has a nice opportunity within their quality services department.
As Quality Services Officer your main goal support the QC laboratories at production sites, affiliates and other divisions with Analytical Reference Standards. You will supply in time qualified Analytical Reference Standards (ARS) with the required accompanying documents and maintain adequate inventory of ARS.
- Guide and control outsourced analyses/studies at several sites, CRO’s and TPM’s for qualification and re-testing of ARS’s.
- Write and review technical documents (protocols, reports) for these analyses. Generate Certificates of analysis.
- Maintain a technical documents archive.
- Know, understand and follow procedures to be applied, related to own activities.
- Accurately records own data and results in a timely manner and in compliance with appropriate quality standards.
- Analyze data, evaluate results, form conclusions, and provide documentation as needed.
- Apply advanced technical writing skills to produce reports and documents; write independently.
- Verify others data and review and/or approve documents from others.
- Communicate with clients about data from various sources to demonstrate how the data meet the client’s needs and timeline for projects.
- Identify and recommend improvements to any aspect of involved areas.
- Maintain quality KPI and other key metrics.
- May perform other duties as assigned.
||Ervaren (3 - 8 jaar)
For the position of Quality Services Officer we are looking for a candidate with a HLO/BSc (analytical) chemistry education.
Further you have:
- > 3 years in pharmaceutical GMP environment.
- Strong focus on customer, quality and compliance.
- Structured thinking and scientific report writing skills.
- Ability to recognize and resolve technical issues by drawing conclusions from data, occasionally supported by manager or (senior) technical staff.
- Fluent in both Dutch and English language.
- Good organizational and planning skills.
- Able to meet tight deadlines.
- Knowledge of pharmaceutical industry with its laws and regulations within the GXP ( GMP) domain, Quality system management and risk assessment tools and techniques, and the ability to apply them in an effective way.
- secondment through Checkmark until 30 December 2018, possible extension
- fulltime position
Neem voor meer informatie contact op met Barbara Razenberg: 0182 590 214