Ashland Inc. (www.ashland.com) (NYSE: ASH) is een internationale producent van specialty chemicals. Ashland heeft productieplants over de hele wereld, waarvan een belangrijke zich in Doel (Antwerpen: Haven - linkeroever) bevindt. Deze chemische plant produceert methylcellulose, dat door klanten wordt gebruikt als additief in de bouw, voeding en farma. Ter versterking van het team is Ashland op zoek naar een (m/v):

 

                                  

                               QA Manager

  

The responsibilities of the position include, but are not limited to, the following:

  • Coordinate and administer the Quality Assurance function for GMP manufacturing.
  • Management and supervision of all QA/QC personnel of the Doel Plant
  • Assure compliance with ISO 9000, ISO 22000 and EXCiPACT standards.
  • Perform risk assessments and maintain QRA and HACCP documentation.
  • Lead local incident and customer complaint investigation and ensure good CAPA resolution using the site CAPA system.
  • Release of all products, intermediates, and raw materials and review of certificates of analysis
  • Conduct Out of Specification (OOS) investigations and evaluate their impact on product quality.
  • Lead all regulatory and customer quality audits. Ensure Supplier management is maintained thru annual risk assessments and audits at pre-determined intervals.  Actively work with Purchasing to identify and resolve any supplier issues.
  • Reconcile and review all batch records for all pharmaceutical/food GMP products.
  • Coordination of all validation activities for Doel products and be the site SME for validation.
  • Track departmental KPI’s and drive continuous improvement.
  • Act as a role model in order to improve the site’s quality culture.
  • Active part of local management team of Doel

 

In order to be qualified for this role, you must possess the following:

  • Minimum of a Master degree in science
  • People management skills
  • 10 years’ experience with ISO Management Systems, pharmaceutical regulatory compliance and chemical and/or pharmaceutical Quality Assurance
  • 5 years’ experience in a supervisory role
  • Strong written, verbal, and computer skills. 
  • Must speak Dutch and English fluently
  • Must be able to apply statistics to problem solving in both QA/QC and manufacturing 
  • Must have experience working with GMP regulations and validation preferably in an excipient, pharmaceutical manufacturing environment
  • Experience working with production and engineering in a manufacturing environment

 

The following skill sets are preferred by the business unit:

  • Six Sigma certification and working with A3 and lean methodology
  • Experience with SAP

 

Interested?

  •  Written applications with motivation can be sent to Marianne Blijweert, HR Specialist, via email mblijweert@ashland.com,
  • Mercuri Urval is our recruiting partner