Job Purpose:
As Conformance Specialist you will develop and provide input to regulatory strategies, change control and compliance issues for the manufacture and registration of established API (Active Pharmaceutical Ingredients), Finished Products and New Product Introductions (NPIs). The role ensures site compliance by the interpretation of corporate standards (e.g. the QMS), pharmacopoeial requirements, regulatory authority directives, license renewals/annual reports and commitments made to regulatory authorities. You will support the Quality Assurance department and all manufacturing units across the site by handling compliance to all licences in all markets supplied (directly or via a packaging site).

Key Responsibilities (include..):

• Provide product regulatory advice for the impact of all changes made on site (e.g. Reg Advice 1) ensuring regulatory compliance in all markets
• Maintain product quality specifications to ensure manufacturing and r...