Product Expert

Want a 3D Career? Join Norgine.

At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.

We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.

Bring everything about yourself that you\’re proud of, whether that\’s your passion for making a difference, focus on others\’ well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.

In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people\’s wellness as much as you do.

Because at Norgine, we transform lives with innovative healthcare solutions.

We have an exciting opportunity for a Product Expert to join Norgine.

Core Responsibilities:

Project Management and Technical Support for new and existing products for all Norgine sites, Contract Manufacturing Organisations (CMO) and partners.

If you want a multi-dimensional 3D career in a leading healthcare organisation, join us.

Requirements

• Provision of technical expertise for planned activities and unplanned business issues.
• Co-ordinate and participate in cross functional teams to complete root cause analysis utilising lean six sigma techniques. Reporting and presenting findings, outcomes and recommendations.
• Planning of and Leadership / Management of GTM projects. Identifying and prioritising tasks on the critical path, influencing and supporting the project team and the wider business. Reporting against key project milestones and Norgine KPIs.
• Manage and/or support process and analytical transfers for any transfers within or involving Norgine sites CMOs and partners.
• Leading the development and continuous improvement of manufacturing and analytical techniques for life cycle management in accordance with GxP, regulatory requirements and company policies and procedures.
• Author and execute Process Validation and Performance Qualification protocols for manufacturing processes at the Hengoed site.
• Author CMC sections of regulatory dossiers and support regulatory compliance initiatives including gap analysis, responding to RFIs, regulatory incidents and post approval commitments.
• KEY RESPONSIBILITIES & ACCOUNTABILITIES:
• Lead and/or provide technical support utilising lean six sigma techniques for investigations linked to Quality Events, Customer Complaints and IMC actions. Provide technical recommendations, co-ordinate and execute CAPA\’s.
• Project Leadership / Management and formal reporting of approved GTM projects for the introduction of new products, new processes, line extensions, technical transfers and continuous improvement initiatives.
• Responsible for Process Validation and Performance Qualification of OSD Products at the Hengoed site and for proposed validation strategies.
• Generate Local and Global Change Controls. Provide impact assessments as a Technical Functional Expert. Lead / Support and/or coordinate the action plans.
• Establish and maintain compliance for all products within the OSD Portfolio in accordance with GxP and company policies and procedures.

RELATIONSHIPS:

• Report directly to the Senior Technical Manager.
• Work cross functionally as a project lead or team member on approved projects with representatives from global and local departments, CMOs and partners.
• Formal reporting of project status to Global Technical Management, Project Sponsors, Site and EN Directors, CMOs and Partners.
• To work closely with the suppliers of raw materials in the development of new and alternative products as well as life cycle management of existing products.
• Management and coordination of expert external resources.

SKILLS & KNOWLEDGE

• Scientific Degree or equivalent possibly a higher qualification in a discipline related to pharmaceutical sciences.
• Extensive knowledge of the pharmaceutical industry with at least 5 years of experience of solid dosage forms.
• Proven Project Management of line extensions, continuous improvement initiatives and technical transfers in a multinational environment.
• Knowledge of the Regulatory compliance requirements within Europe, Japan and the USA.
• Demonstrated experience in the management of root cause analysis investigations utilising lean Six Sigma tools.
• Ability to manage, multiple, cross functional projects to deliver against key project milestones and deadlines.
• Excellent verbal and written communication skills, in English (Other languages desirable e.g. French or German) with the ability to present effectively to groups.
• Excellent influencing skills and ability to establish effective working relationships with personnel at all levels.
• Thorough working knowledge of ICH guidelines and current Good Manufacturing Practices.

Benefits

Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.

Sound good? Find out more about the career you\’ll have with Norgine, then apply here.

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