Materials Quality Associate
Norgine, United Kingdom
Job Description
Norgine are recruiting for a Materials Quality Associate to be a key player in the implementation and management of the quality systems for the control of manufacturing starting materials in line with the Norgine Global Quality and Manufacturing amp; Supply strategy. The position holder will manage a number of commercially critical complex or large sized suppliers. The position holder forms part of the quality team supporting Quality Material Management.
RESPONSIBILITIES
- Significantly contribute in the design and implementation of the quality processes to manage suppliers, proposals sent and discussed with the Materials Quality Manager
- Quality ownership of material suppliers to include API, excipient and packaging suppliers
- Ensure operational quality assurance activities are completed using support from the material suppliers (including but not limited to):
- Change control
- Quality investigations including complaints
- Maintain up to date quality agreements
- Maintain up to date supplier risk assessment
- Plan the design and manage effective complaint handling, investigation and CAPA processes in partnership with external suppliers in line with global procedures.
- Investigate incidents associated with the production of materials supplied to Norgine.
- Manage the review supplier documentation to ensure it meets regulatory and Norgine requirements.
- Manage and perform documentation for supplier and material quality approvals
- Create, negotiate and maintain quality agreements based on corporate QA standards with suppliers.
- Significantly contribute in the design and implement effective supplier risk assessment
- Generate supplier metrics and monthly/ quarterly reports (key performance indicators).
- Leadership and membership/management of specific projects of improvement when required.
- Manage databases and spreadsheets as appropriate for the control of supplier documentation and supplier complaints
- Write and review SOP updates as and when required
- Deputise, if required, for the Materials Management Quality Manager in their absence
- The individual is expected to act as an advocate of global quality and to ensure that their actions and behaviours reflect the norm of the department at all times.
- Adhere to Global Quality and Mamp;S objectives and overall Norgine business strategy.
EXPERIENCE
- A scientific degree is essential
- Experience of working in quality management, supplier management, manufacturing operations, quality control within a regulated industry.
- Process orientated with an ability to work with high attention to detail.
- Experience of working with third party contractors and supplier is desirable.
- Analytically strong with highly developed quality system knowledge
- Previous experience in handling complaints and non-conformances is desirable
- Strong I.T skills in particular Excel and SharePoint
- Strong organisational and well developed planning skills with ability to meet deadlines required
- Ability to establish effective working relationships with personnel at all levels within Norgine and at external contractors and suppliers
- Excellent verbal and written communication skills in English is mandatory and any additional languages would be advantageous
If you would like to be considered for this role, apply today!
This role offers hybrid working.
This role can be based out of Harefield, Hengoed or Dreux.
Norgine has a direct presence in 16 European countries, as well as Australia and New Zealand. We also have a strong global network of partnerships in non-Norgine markets. We are a flexible and fully integrated pharmaceutical business, with manufacturing (Hengoed, Wales and Dreux, France), third party supply networks and significant product development capabilities, in addition to our sales and marketing infrastructure. This enables us to acquire, develop and commercialise specialist and innovative products that make a real difference to the lives of patients around the world.