Validation
il y a 1 semaine
Location:
Wavre
- Type:
Contracting
#20393
QA Validation:
Brabant-Wallon - contracting
#QA #Pharma #Validation
Our partner is looking for a
QA Validation to support their team. This international company is well known for the research, the development, and the commercialization of its pharmaceutical products.
What are your responsibilities?:
The QA Primary Validation services is part of the QA Operations for one MPU.
You will ensure the QA oversight of the continuous validation activities and of the technical services activities for one or several vaccine bulk production units.
Here are your main responsibilities:
- Take part in the establishment, the implementation, the followup, and the maintenance of the continuous validation plan (CVP),
- Assess the validation state of equipment's through writing periodic review report and/or risk assessments
- Write and implement some validation documentation (VP, VSR, Risk Assessment, Gap Analysis),
- Review and approve specific qualification and validation documentation (IQ, OQ, PQ, PV),
- Support the production & technical services teams in the implementation of the validation activities,
- Ensure the periodic oversight of technical services activities,
- Review the modification proposed by the technical teams (MO),
- Ensure adequate level of quality on the floor through gembas and quality coaching of technical teams.
Who are you?:
- You hold a master's degree in Biotechnology, Agronomy, Chemistry or Pharmacy
- You have at least 5 years of experience in a similar position within the pharmaceutical industry
- You have good knowledge of GMP regulated environment related to validation activities
- You speak French and English
- You are proactive, a problem solver and organized
What can you expect?:
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills.
You're interested in this job? We kindly invite you to apply.
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