Project Management and Technical Support for new and existing products for all Norgine sites, Contract Manufacturing Organisations (CMO) and partners.
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.
- 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 G TM 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 KPls.
- 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 of GTM OSD strategy documents for EN Validation and Monitoring activities.
- Author CMC sections of regulatory dossiers and support regulatory compliance initiatives including gap analysis, responding to RFls, regulatory incidents and post approval commitments.
- Report directly to the Associate Technical Director
- 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.
- Scientific Degree or equivalent possibly a higher qualification in a discipline related to pharmaceutical sciences.
- 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.
SKILLS & KNOWLEDGE:
Extensive knowledge of the pharmaceutical industry with at least 5 years of experience of solid dosage forms.