Description
One of our clients, a multinational company in the pharmaceutical industry currently requires a Validation Documentation Support
Start: 15/11
Length: min. 6 months
Location: South of Brussels
KEY RESPONSIBILITIES:
Context:
This job is located within the quality control department and includes regular contacts with production, GTS, quality assurance, validation and suppliers.
Mission:
Documentation management.
Provides support to the quality control (QC) virology team using technical and personal mastery, to provide accurate, compliant and ontime validation reports in accordance
with the clients procedure and cGMP regulations (according Eur. Ph.,CFR, OMS). You will work in a challenging network within QC matrixorganization and other departments.
You will play a key tranversal role in the virology team to follow and maintain the status of quality in the organization and to meet our customer satisfaction
The following tasks are included in the job description:
Writing of validation protocols and reports, procedure testing, taskforce report, request for change (method, biological material, transversal projects).
- Manage the datas needed for validation in collaboration with thevirology team.
- Interact with the virology team to write procedure testing and assessment (risk assessment).
Support and assures the efficiency of QC virology (delay validation reports, performance indicator, action plan).
PREREQUISITES
Education:
* A university certificate with scientific orientation (Bioengineering, Biology, Biotechnology, Pharmacology).
Specific skills & Knowledge:
* Strong knowledge of written and spoken French and English
* Good communication skills
* Ability to work under pressure due to the requested flexibility and reactivity of the activities
* Autonomous
* Ability to work in project teams in a multidisciplinary environment and a matricial organization
Experience:
* High c'GMP knowledge in pharmaceutical field.
Tags: Documentation, Validation, QC, GMP, Pharmaceutical, Pharmaceutique