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:
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Coordinate and administer the Quality Assurance function for GMP manufacturing.
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Management and supervision
of all QA/QC personnel of the Doel Plant
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Assure compliance with ISO 9000,
ISO 22000 and EXCiPACT standards.
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Perform risk assessments and
maintain QRA and HACCP documentation.
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Lead local incident and customer complaint investigation and ensure good CAPA resolution using the site CAPA system.
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Release of all products, intermediates, and raw materials and review of
certificates of analysis
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Conduct Out of Specification
(OOS) investigations and evaluate their impact on product quality.
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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.
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Reconcile and review all batch records for all pharmaceutical/food GMP
products.
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Coordination of all validation activities for Doel products and be the site SME for validation.
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Track departmental KPI’s and drive continuous
improvement.
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Act as a role model in order to improve the site’s quality
culture.
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Active part of local management
team of Doel
In order to be qualified for this role, you must possess the following:
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Minimum of a Master degree in science
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People management skills
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10 years’ experience with ISO Management Systems, pharmaceutical
regulatory compliance and chemical and/or pharmaceutical Quality Assurance
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5 years’ experience in a supervisory role
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Strong written, verbal, and computer
skills.
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Must speak Dutch and English
fluently
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Must be able to apply statistics to problem solving in both QA/QC and manufacturing
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Must have experience working with GMP regulations and validation preferably in an excipient, pharmaceutical manufacturing
environment
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Experience working with production and engineering in a manufacturing environment
The following skill sets are preferred by the business unit:
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Six Sigma certification and working with A3 and
lean methodology
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Experience with SAP
Interested?