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VACATURE
QA ASSISTANT
Waterloo
671462d9-4ac2-4f0f-851c-3a96e6e9bd1a

Statuut
Statuut: Bediende
Bediende
Functioneel domein
Functioneel domein: R&D & wetenschap
R&D & wetenschap
Laborant
Update
Update: 14/2/2022
Provincie
Provincie: Waals Brabant
Waals Brabant
nl
FULL_TIME
Contract type
Contract type: Kans op vast
Referentie
Referentie: 312127
Our client, based in Mont-Saint-Guibert, is an innovative biotech company, with a strong expertise in the development of a unique 3M³ tissue regeneration platform, which utilizes adipose‐derived stem cells within a 3‐dimensional extracellular matrix, to drive multiple product classes.

Your responsabilities;

  • Supervise the strict application of cGMP, GCP and GLP regulations during each step of the production and analysis of batches of experimental medicinal products.
  • Assist with the management ﴾check, approval, distribution﴿ of specifications, work instructions.
  • In collaboration with QC and the QP, assist with the management of the storage facilities for raw materials, intermediates, finished products and packaging materials.
  • Manage the release of materials in close collaboration with the Logistics department.
  • Manage suppliers.
  • Revise batch records from production and quality control data
Monitor archiving and traceability of all quality system documents, with the assistance of the administrative staff when necessary.
  • Assist with the supervision of storage conditions of products, materials and consumables.
  • Assist with the checking and approving of certificates of analysis
  • Assist with the monitoring of storage conditions of clinical batches.
  • Assist with the supervision of assignment of batch numbers to clinical batches.
  • Assist with checking production and quality control procedures.
  • Write, revise and check general production, QC and QA procedures.
  • Assist with checks and monitoring within the QA department
  • Assist with internal audits ﴾scheduling, writing audit plans, carrying out audits, writing reports and monitoring CAPAs﴿.
  • Organise implementation and application of CAPAs following all types of events ﴾OOS, audit, change, etc.﴿.
  • Report any major event to the QA Director immediately.
  • Assist with the review of equipment maintenance and calibration.
  • When required, represent the company and its interests related to activities in the Quality Assurance department ﴾contact with people external to the company, congresses, audits, …﴿

Functieomschrijving

Our client, based in Mont-Saint-Guibert, is an innovative biotech company, with a strong expertise in the development of a unique 3M³ tissue regeneration platform, which utilizes adipose‐derived stem cells within a 3‐dimensional extracellular matrix, to drive multiple product classes.

Your responsabilities;

  • Supervise the strict application of cGMP, GCP and GLP regulations during each step of the production and analysis of batches of experimental medicinal products.
  • Assist with the management ﴾check, approval, distribution﴿ of specifications, work instructions.
  • In collaboration with QC and the QP, assist with the management of the storage facilities for raw materials, intermediates, finished products and packaging materials.
  • Manage the release of materials in close collaboration with the Logistics department.
  • Manage suppliers.
  • Revise batch records from production and quality control data
Monitor archiving and traceability of all quality system documents, with the assistance of the administrative staff when necessary.
  • Assist with the supervision of storage conditions of products, materials and consumables.
  • Assist with the checking and approving of certificates of analysis
  • Assist with the monitoring of storage conditions of clinical batches.
  • Assist with the supervision of assignment of batch numbers to clinical batches.
  • Assist with checking production and quality control procedures.
  • Write, revise and check general production, QC and QA procedures.
  • Assist with checks and monitoring within the QA department
  • Assist with internal audits ﴾scheduling, writing audit plans, carrying out audits, writing reports and monitoring CAPAs﴿.
  • Organise implementation and application of CAPAs following all types of events ﴾OOS, audit, change, etc.﴿.
  • Report any major event to the QA Director immediately.
  • Assist with the review of equipment maintenance and calibration.
  • When required, represent the company and its interests related to activities in the Quality Assurance department ﴾contact with people external to the company, congresses, audits, …﴿
Accent Jobs allie la flexibilité d'une agence d'intérim et la qualité d'une agence de sélection.
Seuls des emplois pouvant déboucher sur un contrat fixe sont proposés. Pour ce faire, nous pouvons nous appuyer sur 700 collaborateurs passionnés qui aident chaque jour plus de 12 000 personnes à trouver un emploi.
Comptant 230 agences, Accent Jobs constitue le plus grand réseau de la Belgique.

Bedrijfsinformatie

Accent Jobs allie la flexibilité d'une agence d'intérim et la qualité d'une agence de sélection.
Seuls des emplois pouvant déboucher sur un contrat fixe sont proposés. Pour ce faire, nous pouvons nous appuyer sur 700 collaborateurs passionnés qui aident chaque jour plus de 12 000 personnes à trouver un emploi.
Comptant 230 agences, Accent Jobs constitue le plus grand réseau de la Belgique.
Your profile:

  • You have a scientific or technical degree ﴾Bachelor or equivalent experience﴿
  • You have knowledge of GMP, preferably with at least one year's experience in a company, knowledge of working in aseptic conditions would be an asset.
  • Knowledge of all other quality system norms and guidelines would be an asset
  • You have basic computer skills
  • You have very good knowledge of French ﴾written and spoken﴿, good knowledge of English ﴾written and spoken﴿
  • You are thorough and respect procedures, you have excellent communication and analytical thinking skills

Jouw profiel

Your profile:

  • You have a scientific or technical degree ﴾Bachelor or equivalent experience﴿
  • You have knowledge of GMP, preferably with at least one year's experience in a company, knowledge of working in aseptic conditions would be an asset.
  • Knowledge of all other quality system norms and guidelines would be an asset
  • You have basic computer skills
  • You have very good knowledge of French ﴾written and spoken﴿, good knowledge of English ﴾written and spoken﴿
  • You are thorough and respect procedures, you have excellent communication and analytical thinking skills
Accent Jobs est parfaitement conscient que le marché du travail est constitué de différents groupes cibles, chacun ayant ses propres souhaits et exigences.
Nous gérons cette diversité en l'abordant à travers différents départements spécialisés.
Ainsi, nous pouvons aider chaque personne en connaissance de cause.
Lors du processus de candidature, nous jouons le rôle du coach pour vous apporter aide et conseil. Notre objectif? Vous aider à dénicher le job de vos rêves!

Wij bieden jou

Accent Jobs est parfaitement conscient que le marché du travail est constitué de différents groupes cibles, chacun ayant ses propres souhaits et exigences.
Nous gérons cette diversité en l'abordant à travers différents départements spécialisés.
Ainsi, nous pouvons aider chaque personne en connaissance de cause.
Lors du processus de candidature, nous jouons le rôle du coach pour vous apporter aide et conseil. Notre objectif? Vous aider à dénicher le job de vos rêves!
Chat
Chat met dit kantoor
Neem contact op met Mathilde via +32 67 34 76 11
Erkenningsnummer: W.INT.040
Diversiteit en inclusie zijn belangrijk voor Accent. Wie, wat of hoe je ook bent of waar je voor staat, het zijn jouw talenten die het verschil maken.

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