Job Title: QA Associate 1: Functional Administrator
The function requires the ability to think and make decisions independently related to application administration and support.
The job deals with routine problems and activities (60%) that are occasionally reviewed; a flexible attitude towards work is important. The job deals partly with activities of a nonrepetitive kind for which a good understanding of computerized Quality Systems, data acquisition, reporting, process control and GMP requirements are necessary.
The function requires the ability to deal with the requests of user groups, the objectives of the Quality department and the site, and to make acceptable decisions at contradicting interests.
The function requires good communication and interpersonal skills and the ability to perform well in a team. Good administration skills and an affinity for administration are a "must"
This position requires experience in the pharmaceutical business as well as computerized systems knowledge. This means experience working within a controlled systems environment.
What, Including, but not limited to…
- Administers computerized systems within JBV such as complaince wire, Trackwise or tru Vault. Provides 2nd- line functional application support for Quality computerized systems within JBV. Accommodates incremental application changes including all associated user requests and documents.
- Provides 2nd line functional application support to local Super Users and End Users for Quality computerized systems by answering functional questions and performing support tasks in the application (related to business processes).
- Participates in short- and long-term projects.
- Supports and performs tasks for the Supervisor QSDM.
- Uses Systematic and structural approach on improvement projects, utilizing the necessary tools such as JJOS
- Responsible for Metric reporting for QSDM / GMP Training
How, Including, but not limited to…
- Connect: Acts as part of the team and executes the systems and processes under supervision
- Shape: Assists senior levels in QSDM / GMP Training processes, document management.
- GROW: Builds competency in operational processes which include Training processes and document management. Demonstrates technical skills to perform job functions. Increase 'big picture' on GMP and site awareness
- Able to work accurately
- Good communication skills, knowledge of English Language
Education & Experience
- Education: Typically, will have a Bachelor’s degree or Technical Secondary high school.
- Experience: Typically, 1- 3 years’ experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industries. Experience and knowledge of computerized systems, affinity with administration
Janssen Biologics (7266)Job Function
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