Associate for documents/ training/ compliancy - Life Sciences

10-10-2018 zwijnaarde
job description

A biopharmaceutical company in Gent is looking for new employees.
At this moment we are hiring a new associate who will be responsible voor training & document
Be part of the quality department responsible for supporting the document, sample, training management and archiving in compliance with the GxP and R&D requirements.
Key Responsibilities:
In the role of Document Manager
1. You make the active Controlled Quality Documents available for Ablynx
2. You move the obsolete Controlled Quality Documents to the archive
3. You manage the document coding of the Controlled Quality Documents
4. You follow-up on the periodic review of the Controlled Quality Documents
5. You are responsible for the document management system and provide training on request
6. You support QA Lead during inspections from external organizations
In the role of Archivist
1. You archive documents and samples conform the GxP requirements
2. You manage the archive conform the specific procedures
Training Manager
1. You manage the training system
2. You are responsible for maintaining the training records up to date for the GxP environment
Publisher
1. You maintain the templates of reports up to date and centrally available
2. You perform an eCTD compliance screening on eCTD compliant documents
Skills, expertise and contribution:
Administrative consciousness and correctness
Organizational skills: good organization skills to be able to follow-up documentation and actions related to multiple audits
Team player, good communication and negotiati

your contribution

Professionele Bachelor biomedische laboratoriumtechnologie Professionele Bachelor chemie Professionele Bachelor

Skills, expertise and contribution:
Administrative consciousness and correctness
Organizational skills: good organization skills to be able to follow-up documentation and actions related to multiple audits
Team player, good communication and negotiation

Minimum Qualifications:
Expected educational qualifications: at least a Bachelor degree
Expected experience: 2-3 years experience in a Quality department, preferably in the biotechnology domain
MS Office: Very good
Very good knowledge of English

summary
function
technical employee (m/f)
employment type
full time
contract type
immediate permanent employments
sector
Boekhoudkundig en juridisch
reference
DUORS-1032832
your Randstad contact
Sophie Vanden Hole of Ellen Cosijn
hightechnics_gent@randstad.be 09/2699887 of hightechnics_gent@randstad.be
09/2699887 of hightechnics_gent@randstad.be

office info
Gent Brabantdam 70
Brabantdam 70
9000 GENT
003292699898
003292699898