Quality Manager Europe (GMP)
|Datum vacature||25 mei 2020|
Our client is a specialty chemicals company with more than 30 locations worldwide. In the region Europe they have locations in Finland, Scotland and the Netherlands. There they produce addditives for food, pharma and cosmetics. For this region we are searching for a Quality Manager Europe.
In this high visibility position you are responsible for overseeing quality and GMP programs for the EU region. You are primarily responsible to ensure global quality objectives are implemented and maintained with Safety as the core value followed by quest for quality excellence. You assure consistent product quality and regulatory compliance by establishing and maintaining quality and GMP systems, hosting audits (internal, vendor, customer, regulatory), validating processes and test methods, maintaining certifications and handling customer complaints and corrective actions.
Responsibilities / Duties:
- Oversee establishing and institutionalizing management systems to comply with ISO standards and GMPs as applicable to the operations. Provide regional leadership to ensure compliance with safety, GMP, and environmental regulations.
- Ensure all third party certifications are kept current and systems are updated as necessary. Ensure ongoing GMP compliance and certification (as applicable)
- Manage internal audit program and ensures audits are completed and corrective actions implemented in a timely fashion
- Support customer, third party, or regulatory audits/inspections and coordinates responses and corrective/preventive actions
- Control complaint handling system at regional level and ensure investigation and corrective actions are timely and effective
- Oversee vendor quality programs and audits suppliers as necessary. Monitor regulatory compliance at key suppliers as applicable
- Administer product recall program and conduct periodic mock recalls
- Establish and monitor Basic Quality Process (BQP) at sites and promote a culture of continual improvement
- Maintain and report quality KPIs on an ongoing basis, identify trends and plans for improvement
- Support global quality initiatives and ensure they are harmonized and implemented at the regional level
- Ensure laboratories are set-up and equipped to meet all in-house inspection and testing needs.
- Support global quality excellence roadmap and establish quality goals and objectives for regional sites aligned with corporate roadmap
- Facilitate continuous improvement of product quality through annual product reviews, Cpk analysis, annual review of production standards, etc. Prepare quality reports for customers and Production as needed.
- Collaborate with other members of management to develop new products and applications, implement new manufacturing and test methods and conduct training
You are based in Amsterdam with visits to the locations in Finland and Schotland. You manage the local QHSE Managers in Finland, the Netherlands and Scotland. In this role you report to the Global Quality Director.
- Bachelor’s degree in Chemistry, Biology, Chemical Engineering, etc. Master’s degree preferred.
- 8 - 10 years QA/QC Managerial experience in a GMP environment and a manufacturing site
- Demonstrably experience in Health, Safety and Environment
- Good knowledge of ISO standards (9001, 14001, 45001), FSSC 22000 with internal auditing experience
- Proficiency in GMPs – food, pharma, cosmetic, API
- Working knowledge of SPC and LIMS
- Experience with developing systems and procedures
- Computer Proficiency
- Quality and compliance oriented with hands-on leadership skills
- Ability to work independently with no direct supervision.
- Good team player with lateral leadership capability
- Good verbal and written communication skills
- Attention to detail, thoroughness, ability to deal with complex situations
- Fluent in Dutch and English
Wat bieden wij
We offer an interesting and challenging job in a worldwide operating company.
Want to know more? Please contact Alice van den Berge at firstname.lastname@example.org or 06-40526368.
QHSE-Professionals is een werving & selectie en recruitmentsupport bureau voor vaste banen en interim functies op het gebied van Quality, Health, Safety & Environment (Kwaliteit, Veiligheid, Arbo en Milieu). Wij bemiddelen in functies als SHEQ Manager, Kwaliteitsmanager, KAM Coördinator, Quality Assurance Officer, Manager HSE, Veiligheidskundige, QA engineer, QHSE Advisor, KAM Coordinator, HVK ’er en MVK ’er en werken voor opdrachtgevers in onder meer energie, afval, recycling, food, farmacie, facilitair, scheepvaart, olie & gas, chemie, kunststof, offshore, metaal, bouw, infra, maritime, automotive, ICT en logistiek
Eigenschappen van deze vacature
- Voedingsmiddelen, Drank en Agri
- ISO 45001
- OHSAS 1800
- ISO 14001
- FSSC 22000
- ISO 9001
- 5 - 10 jaar
- 10+ jaar