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Development Lab Quality Operations Partner

  1. Belgium, Brussels
Brussels
  1. Contract
Competitive
  1. CAPEX Projects
36886
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 Development Lab Quality Operations Partner - Brussels, Belgium - 8 Months Contract

We are looking for an experienced  Development Lab Quality Operations Partner for a fantastic 8 month contract based in Brussels.

You will be working with our client who are a global biopharmaceutical organisation committed to improving the lives of people afflicted with neurological and immunological disease.

This is a superb opportunity if you are looking to advance your career in the field with a supportive and innovative company that will put you first.

Responsibilities:
  • Drive continuous quality improvement process, ensuring that the Quality Management System in support of product development and clinical supplies, work in a way that ensure product quality, safety and efficacy, meet regulatory requirements and expectations and operate in a fit for purpose and in a smarter way.
  • Provide support to build the end to end “issued copy process’ for DEV/DSC entities.
  • Act as Reconciler by checking the correct completion of the “issued Copy” process,
  • Coordinate the development local instructions, liaise with dev key stakeholders in order to maintain common practices with regards to “issued copy” within development entities” ensuring appropriate application of the “issue copy process.”
  • Provide support during regulatory inspections, and quality improvement initiatives. You will contribute the preparation of audits (internal/external, regulatory inspections)
  • Provide guidance and expert advice to development scientists, particularly with regard to the appropriate interpretation of national and international GMP regulations and guidelines
  • Identify, mitigate and subsequently resolve compliance and quality issues that may affect development activities and products. These lessons learned, once implemented, shall then form the basis for future cross functional and cross project training and improvement opportunities.
  • Support QA activities for all Dev QA entities ( Lab, pilot plant,…..)
  • Maintain and continuously improve Quality systems and processes in place for the appropriate documentation of development activities and ensure compliance with regulatory and corporate requirements.
Requirements:
  • Master’s or bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, or Quality Management).
  • Relevant experience in data integrity and documentation control within the biopharmaceutical industry.
  • A good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential.
  • QA/compliance experience in DS/DP/IMP manufacturing, facility operation, laboratory compliance and quality systems is an asset.
  • Good written/oral communication in English
  • Ability to work autonomously for the assigned activities with limited supervision
  • Must be able to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments
If this role is of interest to you, please apply now!

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