Senior Manager Quality Assurance
il y a 2 semaines
We are seeking a Qualified Person -QP-/ Senior Quality Assurance Manager to oversee all quality and compliance aspects related to Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and HACCP for Food Supplements in Belgium, Luxembourg, and the Netherlands. This role is critical in ensuring that our products are manufactured and distributed in compliance with applicable regulations and global quality standards. You will work closely with the supplier qualification team in the qualification of new raw materials. You are also the central contact person for quality-related questions.
This role offers a hybrid working model of 3 days on-site and 2 days working remotely
Your tasks as "Qualified Person / Senior Quality Assurance Manager (m/f/x)"?
- Act as Qualified Person in accordance with Article 84-86 of the Royal Decree of 14 December 2006 relating to Medicinal Products for Human Use.
- Act as Responsible Person for Distribution in accordance with the directive 2001/83/EC and the Royal Decree of 14 December 2006 relating to Medicinal Products for Human Use.
- Ensure each batch is QP certified before it is placed on the market or exported to a third country including the maintenance of the certification register.
- Ensure proper documentation and quality/technical agreements with all parties involved in product manufacturing, testing, and distribution.
- Maintain a documentation system aligned with Global Healthcare procedures.
- Ensure Audit and qualification of all parties involved in product manufacture and testing.
- Ensure a system to secure complaint from GMP/GDP critical vendors by: maintaining a vendor list, establishing Quality Technical Agreements, assuring vendors audits are regularly planned and performed and assure the products are manufactured in line with the Marketing Authorization,
- Lead and manage critical quality incidents, product complaints, product recalls, withdrawals and interact with drug and food safety department as well as authorities in the case of relevant issues.
- Prepare for and manage authority inspections.
- Approve and oversee the yearly training plan and ensure personnel are trained and qualified as required.
- Identify, record, and investigate deviations.
- Define and track corrective and preventive actions to continuously improve quality processes.
- Monitor and report Quality Indicators.
Your requirements as "Qualified Person / Senior Quality Assurance Manager (m/f/x)"?
- Master's degree in pharmacy.
- Registered and approved by the Belgian Authorities as Qualified Person in accordance with the Royal Decree of 14 December 2006
- 4-6 years of hands-on experience working in the (pharmaceutical) industry
- Advanced knowledge of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).
- Proficient in English and Dutch - French would be a plus
- Strong communication and cooperation skills with internal and external stakeholders.
- Result-oriented with a quality-minded approach.
- Well-organized with a good sense of urgency.
Information about our client:
Our client was founded over 150 years ago and has developed into the world's leading consumer goods company with a portfolio including some of the most trusted brands on the market. Their product portfolio includes 60+ individual brands with one of them being "Personal Health Care", where this position will be located. The client operates in more than 100 countries worldwide and has almost 100.000 employees.
My contact details:
Email: s.gotzler@sciproglobal.de
Tel: 0049 (0) 89/26 20 58 887 (direct dial)
LinkedIn:https://www.linkedin.com/in/sebastian-gotzler-39617a15a/
I look forward to your application
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