Description
Validation / Qualification EngineerLocation: Basel Area
Start date: 01.05.2018
Duration: 4 to 6 months
Hours per week: 40 % - 60 % at the beginning, to 80 % - 100 % later on
Tasks:
1. Investment Projects
Is member of project teams for investment projects and coordinates associated validation/qualification tasks, writing user requirements, proposes strategy in relation to qualification and validation for new equipment and processes and updates the validation master plan.
2. Process Validation
Position holder is the process validation Subject Matter Expert on site, has the conceptual lead in the process validation topic and presents it during health authority inspections, establishment of the Validation master plan, Supports Quality functions in writing of Product Quality Reviews and Annual Product Reviews with respect to process/quality data analysis and trending.
3. Cleaning Validation
Position holder is the cleaning validation Subject Matter Expert on site, has the conceptual lead in the cleaning validation topic and presents it during health authority inspections, including writing cleaning validation documents and establishing risk assessments.
4. Clean Room/HVAC Qualification and Monitoring
The clean room/ HVAC qualification SME on site, has the conceptual lead in managing the qualification topic in collaboration with Contracted Service Providers and presents it during health authority inspections, Oversees all clean room/ HVAC qualification activities performed by the Contracted Service Providers (master validation plan), Reviews/Approves qualification documents created by the Contracted Service Providers and Oversees all monitoring data and issues corresponding reports.
5. Utility Qualification
Position holder is the utility (e.g. nitrogen, purified water) qualification Subject Matter Expert on site, has the conceptual lead in managing the qualification topic in collaboration with Contracted Service Providers and presents it during health authority inspections, Oversees all utility qualification activities performed on site, Reviews/Approves qualification documents, Oversees all monitoring data and issues corresponding reports.
6. Various Tasks
- Performs special tasks for the Associate Director, Manufacturing
- Supports investigations related to process deviations and product quality
- Participates internal audits and audits of regulatory agencies.
- Supports electronic and paper-based archiving of documents related to his role
- The post holder informs his superior of extraordinary events in his area of activity.
- Support the creation of manufacturing related SOP
Desired Background:
Education in Chemistry, Chemical Engineering or Life Sciences (Bachelor, Master an asset)
- Has at least 3 years of work experience in performing qualification/validation activities in the pharmaceutical industry, experience in API manufacturing an asset
- Good knowledge of both English and German
- Has a basic understanding in statistics, is willing to continuously further develop his knowledge
- Has an understanding in common risk assessment methodologies, is willing to continuously further develop his knowledge
- Strong ability to take ownership and responsibility
- Effective, competent communication style
- Experienced in common computer software (Windows, MS Office, etc.)
If you are interested, please send you updated CV to: or give me a call under the following number:
Looking forward hearing from you
Kaja
Real Staffing
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.