Sterility Assurance - 10161

4-12-2019 wavre
company profile

Our client is a global vaccine research, development and production company, that employs over 11,200 people worldwide, of which 7,500 in its three Belgian sites: Rixensart, Wavre and Gembloux.

job description

Are you a Junior Sterility Assurance who's looking for a new professional project in a Pharmaceutical Industry ? 

Feel free to contact me : megane.libert@cx.ausy.be / +32(0)497/61.85.75

Provides support and expertise to the operations to ensure that the Manufacturing Performance Unit applies Sterility Assurance processses (aseptic practices, environmental monitoring, cleaning and sanitization, sterilization, media fill,...) to confidently deliver products to patients with the highest sterility level at an appropriate cost. 

  • Support for the follow-up of procedures in the field
  • Write environmental reports
  • Reading of sample boxes
  • Results encoding 
  • Drive and execute continuous improvement project or remediation plan related to sterility assurance, including change control management, SOP's review,...
  • Manage relationship with aseptic operations in the context of the tasks described
  • Identify potential quality and compliance risks and help to manage theses risk through the existing quality systems 
  • Performs gap analysis, system effectiveness reviews and other management reviews, as required
  • Guarantees the maintenance of the cGMPs in the area of responsibility (SOP, documentation, audits, training, method, validation)
  • Ensures and supports the implementation of adequate training and practices related to sterility assurance, including shop floor mentoring as required
  • Contributes to inter-MPU QA meetings to share knowledge and practices and to review sterility assurance issues as to foster continuous improvement and manage risks

your contribution

  • Experience in Sterility Assurance
  • Experience in QA in the Pharmaceutical Industry
  • Experience in GxP
  • PhD or Master in Sciences (microbiology, engineering, bio-engineering, pharmacy,...) or equivalent by experience
  • SAP - Excel - Word
  • Fluent in French
  • Good knowledge in English
  • Hands-on approach
  • Able to work on the shop floor with a coaching and mentoring style to impact individual experiences 
  • Strong communication skills with all levels
  • Influencing skills
  • Builds trusts and rapport with others
  • Flexible mindset
  • Knowledge sharing
  • Achievement oriented

what do we offer?

We offer an attractive salary with extra-legal advantages :

  • Group insurance
  • Hospitalisation insurance
  • Meal vouchers of 7 euros gross per working day
  • Reimbursement km or company car
  • Monthly allowance (50 euros net per month)
  • A 13th month
  • Training
  • Etc

A rate as freelance is also possible !

summary
function
quality and environment specialist (m/f)
employment type
full time, freelance
contract type
long term contracts
reference
CXRSP-87042
your Randstad contact
Libert Mégane
megane.libert@cx.ausy.be 02 474 60 16
02 474 60 16