My Client a Global Generic’s company have opened 2 new vacancies within their Technical Division; they are actively looking to recruit 2 Technical Specialist to their team on a fixed term contract basis, to their offices in London.
MAIN PURPOSE OF ROLE:
Support and improve the on-going supply of difficult to make products through on-site support to contract manufacturers.
Provide technical services to Regulatory and quality, support scientific and technical due diligence as required and provide expert input in to MA/Manufacturing compliance.
Deliver specific projects that include site transfers, changes to API sources, reformulation and process improvement.
· Provision of technical support and expertise to all relevant activities within the business unit
· Project management of assigned projects
· Authoring, review and approval of technical documentation (BMRs, technical reports and summaries ,etc.) to support manufacturing & regulatory activities
· Authoring, review and approval of sections of Regulatory Dossiers (Module 2 and Module 3) in CTD format for use in all submission related activities
· Management of and participation in, technical transfer activities with associated document authoring and review
· On site attendance at manufacturing sites to resolve manufacturing/technical issues affecting continuity of supply of all products
· Other tasks as delegated by Line Manager which contribute to overall running of the business unit
· Strong Life Sciences Background
· Excellent experience within Formulation Development
· Knowledge of CMC
· Prince 2 Experience nice to have.
· Fluent in English.
For more information regarding this vacancy or a confidential job discussion, please get in touch with Neal Panting. Neal@arc-7.com or +441483 397070