Quality Assurance Specialist

☞ Sharp Packaging Solutions

看过: 145

更新日: 26-11-2025

位置: Hamont-Achel Limburg

类别: 市场/公关

行业:

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工作内容

Functieomschrijving:
Act as a Quality Assurance Specialist assisting the Qualified Persons in ensuring that each batch has been manufactured and checked in compliance with the laws in and in accordance with the requirements of the marketing authorization.

  • Application of all elements of the Quality Management System and as such support the Lead QP in his/her tasks to ensure each batch has been manufactured and checked in compliance with the laws and in accordance with the requirements of the marketing authorization
  • Evaluate Changes proposed through the Change control system.
  • Review final investigation reports on incidents, complaints and investigations.
  • Participate in the enhancement of the Sharp quality system to assure the right cGMP level for the process and systems at Enestia (Sharp) Hamont NV.
  • Participate in cGMP improvement activities.
  • Participate in projects and contribute to: project execution, validation activities and strategy, compliance to existing legislation or customer requirements and correct implementation of the project in the production environment.
  • Participate in projects and be review validation documents up to the PV protocols.
  • Report progress on projects and related validation activities in weekly meetings with delegate QP’s and lead QP.
  • Perform and/or assist with parts of various problem-solving duties which occur, including studying the situation, evaluation of possible solutions and options, deciding on most appropriate plan for solution, and approving plan of action
  • Provide training to other employees by demonstration, repetition, modelling, large group training, etc.
  • Assist in controlling the correct working of the quality management system. Oversee the quality system and evaluate Change requests, CAPA plans and outcome of quality reviews
  • Prepare and redact APR / PQR on a timely basis.
  • Batch documentation integrity, by means of batch record review, review of analytical records and other relevant batch information.
  • Advice of internal deviation handling and CAPAs.
  • Key support role in client and authority audits of Sharp.
  • Act as co-auditor during supplier audits.
  • Act as (co)-auditor during internal audits
Profiel:
  • Master degree, industrial pharmacist or equivalent (eg. Master in biomedical sciences, Master of Bio-engineering).
  • Completed relevant training and courses in Pharmaceutical Manufacturing
  • Experience with drug (secondary) packaging processes is an advantage
  • A thorough first experience of 3-5 years
in a Quality Assurance Specialist role pharmaceutical manufacturing
  • Active in depth knowledge on international cGMP guidelines and pharmaceutical regulations.
  • Knowledge of other Quality Management Systems (HACCP, Food Regulations, Medical Device regulations) can be an advantage
  • Ownership
  • Team player, able to work with all levels in the organization
  • High level of integrity
  • Think in processes
  • Positive mind set / Think in solutions
  • Decision maker
  • Accurate
  • Organized work processes / set priorities
Aanbod:
Sharp Packaging Solutions offers you a versatile and challenging job in a dynamic work environment. We create growth opportunities and, in addition to a competitive salary package, we offer you numerous additional benefits.
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最后期限: 10-01-2026

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