VALIDATION ENGINEER - QUALITY MB

Job description

BELGIQUE(Lessines)
du01 octobre 2020au01 octobre 2022(pour24mois)
ETABLISSEMENT :BAXTER SAS
REMUNERATION MENSUELLE :1815€ (indemnité non contractuelle fixée par décret et arrêté, dont le montant peut varier notamment en
fonction de l’évolution du barème de référence, de la localisation de la mission et des cas d’abattements prévus par les textes)

Entreprise:

Baxter touches millions of lives every day. Our products and services are essential building blocks of healthcare. You’ll find Baxter’s products and therapies on nearly every floor, in every department, in almost every hospital worldwide. You’ll find us in clinics and in the home. Patients and providers rely on Baxter for lifesaving renal and medical products, including intravenous (IV) solutions, systems and administrative sets, IV infusion parenteral nutrition, perioperative care, pharmacy devices and software, acute renal care, and home and in-center dialysis.

Poste et missions:

Coordinate and support validation activities for sterile drugs department (finished products on a pharmaceutical site) working closely with Quality, Engineering, Automation, Production and Research & Development departments.

* Act as a validation representative for projects that include validation :

- Define the validation methodology and approach for the project.
- Provide validation expertise and quality assurance guidance for the development of the project: direct involvement in the definition of the process/system specifications.
- Participate in the risk assessment related to the project.
- Review specification document for validation requirements and all applicable QA requirements.
- Participate in the determination of process or system controls.
- Prepare and implement FAT, IQ, OQ, PQ, cleaning and process validation protocols.
- Assure traceability throughout the whole project validation file (from specification to PQ).
- Organize and coordinate FAT, IQ, OQ, PQ, Process validation activities with the different involved departments and in such a way that all of them concur to the timeframes committed with the project leader.
- Analyze, interpret, document and report the testing results.
- Ensure the follow-up and tracking of the validation’s activities. Update the validation documentation system.
- Perform periodic validation for equipment and processes

* Benchmark of compliance program, inside and outside the company

* Develop procedures in compliance with Corporate and Industry requirements
* Develop and manage (re)validation program

Profile:
- Pharmacist or Engineer with experience or traineeship in validation and/or Quality
- Good knowledge of current European and FDA regulations
- Good Communication skills
- Good problem solving and critical thinking skills
- Good knowledge in statistical analysis
- Good knowledge of English
- Versatility, autonomy, rigor and reactivity