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Ashland Specialties Belgium

Quality Assurance Manager

People person with quality expertise in the pharmaceutical industry
Published on Jobat.be 14 days ago

Quality Assurance Manager

Ashland Inc. (www.ashland.com) (NYSE: ASH) is an international manufacturer of specialty chemicals. Ashland has production sites worldwide, including an important plant in Doel (port of Antwerp, Linkeroever). This plant produces methylcellulose, used as additive in the construction, food and pharmaceutical industry.

Job description

  • You manage and supervise all QA/QC personnel of the Doel Plant, 3 of whom are your direct reports.
  • You assure compliance with ISO 9000, ISO 22000 and EXCiPACT standards.
  • You perform risk assessments and maintain QRA and HACCP documentation.
  • You release all products, intermediates and raw materials and review certificates of analysis.
  • You conduct Out of Specification (OOS) investigations and evaluate their impact on product quality.
  • You lead all regulatory and customer quality audits. You ensure that supplier management is maintained through annual risk assessments and audits at pre-determined intervals.
  • You actively work with Purchasing to identify and resolve any supplier issues.
  • You reconcile and review all batch records for all pharmaceutical/food GMP products.
  • You coordinate all validation activities for Doel products and you are the site Subject Matter Expert for validation.
  • You track departmental KPIs and drive continuous improvement.
  • You act as a role model in order to improve the site’s quality culture.
  • You report to the EMEA Quality Group Lead and the local plant manager, plus you are part of the local management team.

Profile

  • You hold a Master degree in a science-oriented field.
  • You have 10 years of experience with ISO Management Systems, pharmaceutical regulatory compliance and chemical and/or pharmaceutical Quality Assurance
  • You have 5 years of experience in a supervisory / leading role.
  • In addition to a quality expert, you are also a people person and manager.
  • You have strong written and verbal communication skills in Dutch and English, topped with decent computer skills.
  • You are able to apply statistics to problem-solving in both QA/QC and manufacturing.
  • You are familiar with GMP regulations and validation, preferably in an excipient, pharmaceutical manufacturing environment.
  • You have experience in working with production and engineering in a manufacturing environment.
  • Six Sigma certification, working with A3, lean methodology and SAP is preferred.

Offer

Ashland Specialties Belgium is a growing organisation with a positive and open environment in a stable, international group that pays a lot of attention to the competenties and interests of the individual. This role is a challenging job with a high level of reponsibility, which includes being part of the local management team and leading a team of 3 direct reports.
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    25 days left to apply

    Characteristics

    • Function type: Quality
    • Sector: Chemistry and Pharmacie
    • Eastern Flanders
    • Antwerp
    • Abroad
    • Antwerp & Port of Antwerp
    • Sint-Niklaas
    All jobs via Mercuri Urval

    Requirements

    • Master (University or Higher Education Long Type)
    • English

    Offer

    • Permanent
    • Full-time
    • Company car

    Apply before

    • 16 March

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