Ashland Specialties Belgium is looking for a QA Manager to lead the Quality department and assure compliance with international standards, regulations and customer requirements in an international pharmaceutical manufacturing environment.
Responsibilities and tasks
- 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.
- 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.
What We 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.
We look forward to hearing from you
We are working in collaboration with Mercuri Urval, specialists in Executive Search, Professional Recruitment and Talent Advisory.
Please send your CV and cover letter through www.mercuriurval.com (ref.no. BE-05511).
For additional information please contact Michael Leliaert or Diana Van Dijk via +32 11 287828.