Regulatory Conformance Specialist

The Quality function promotes quality and compliance through the product life-cycle in the manufacturing and production operations across GSK Sites. The team supervises all Regulatory compliance related systems, improvement procedures and documentation (including analytical data and information) to ensure products released have been manufactured and packaged according to all Regulatory and cGMP requirements (including appropriate certification for the UK/EU markets).

Job Purpose:

As (Regulatory) 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 mad...