Consultant Opérationnel QA

18-4-2019 wavre
company profile

Our client – one of the world’s leading
research-based pharmaceutical and healthcare companies – is committed to improving
the quality of human life by enabling people to do more, feel better and live
longer.


job description

You have at least 5 years experience  in the Pharmaceutical/Biotech industry with significant experience of GMP ? 

Contact me : Aurelia.sautiere@cx.ausy.be


The
purpose of the role is to assure and maintain the organization of the
activities linked to the quality oversight of the manufacturing activities in
the new production building of Hepatits A bulk production and in priority the
resolution of the deviations and definition and follow up CAPA actions
linked to the deviations.



By
the quality oversight and deviation follow up of the manufacturing process
define action plan in collaboration with the production team to assure that the
quality systems are in place and in use to produce consistency batches. 

Some responsibilities :



  Ensure follow up of the meetings
linked to the deviation handling and support the QA operational team in the
organization of deviation review



 Review and approbation of deviations



  Ensure a regular workshop in production
areas; verify the respect of GMP and procedures in place and identify
gaps/deviations, define action plans in collaboration with the production team



 Participate
the implementation of the quality systems in the new production building to
assure compliance of consistency campaign and the commercial production



  Give support to the approval of change
controls linked to the deviations



•  Identify, Develop and Implement
improvements to the quality oversight processes



 


your contribution


University degree: master degree in Sciences/Engineering e.g. Pharmacist /
Master in Sciences / Bio Engineer pharmaceutical

Minimum 5 years in the Pharmaceutical/Biotech industry with significant
experience of GMP

French fluent and professional English is a plus 
• Preferred knowledge
of vaccines and/or immunology process and products (manufacturing)


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
immediate permanent employments
reference
CXRSP-80792
your Randstad contact
Aurélia Sautière
aurelia.sautiere@cx.ausy.be 0493/60.71.03
0493/60.71.03