QA Specialist

  • Location: Braine l'Alleud
  • Type: Contracting
  • Job #18481

QA Specialist 

Brabant wallon – Contracting 

This position will directly support Alliance Partnership to ensure the proper oversight, from a global quality perspective of the activities that our client is performing for all global alliance partners distributing or receiving global products to/from the different entities of the company.

Your responsibilities ? 

  • Maintain an inventory of the different types of Alliance Partnership where the company QA involvement is required
  • Make the link between the Alliance Management Database, the Database of  Supply chain commercial services and the QA approved customers
  • Create, review and revise quality agreements and related appendices as required to ensure they are maintained up-to-date
  • Ensure partners are audited where required according to the appropriate frequency
  • Maintain and upload all Quality Agreements into the Documentation Management System (DMS)
  • Support of launches of global products with partners
  • Assist in sops, deviations, change control, recalls and complaints handling related to alliance partners (including creation, review and/or quality approval as appropriate)
  • On-going communication with different partners on multiple global quality topics, including review/approval of deviations, changes, recalls  and complaints
  • Design and maintain a collaboration site where all the QA relevant information with respect to Alliance Partnership will be stored and accessible.
  • Assistance in the company projects with impact on partnerships and Global QMS
  • Drive & coordinate continuous improvement projects that will lead to improved Quality KPI and product/process quality. Monitor and update on regular basis owned quality KPIs.
  • Ensure communication of compliance status and issues to appropriate levels of the organization.
  • Support of Regulatory activities with partners
  • Participate or support the preparation for audits/site inspections and provide direct support to System Owners and main customers during audit or support for inspections
  • Drive the identification of opportunities for improvement, development and implementation of quality and operational excellence projects in response to business requirements, technical changes, identified risks, audit observations and regulatory requirements at the QA Alliance site
  • Ensure Management Review takes place according to the company MR Policy

Your profile ? 

  • Scientific Master degree or college diploma (Pharmaceutical, Medicine, Chemistry, Biology…)
  • Knowledge in GMP, GDP and pharmaceutical environment, knowledge of quality agreements is an asset
  • At least 3 years working experience in a pharmaceutical environment
  • Must be able to communicate fluently in English (communication with other company's sites and partner required)
  • Other language is a plus
  • Strong analytical mind-set
  • Negotiation skills
  • Strong written and oral communication skills
  • Self-driven, results-oriented with a positive outlook and a clear focus on high quality

Our offer ? 

We offer you a permanent contract and an attractive salary package. You will also have the opportunity to develop personally and professionally through internal training.

If you are interested, don't wait any longer!

Apply directly via our website WWW.JEFFERSONWELLS.BE or send your CV to the following email address [email protected]

 

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