Quality Specialist- 12 Month Contract
*This role offer flexible working options*
I am working with a global pharmaceutical company in Hertfordshire who is looking for a Quality Specialists to join their team on a 12-month contract.
As a Quality Specialist you will be responsible for implementing a controlled document strategy for all relevant regulatory compliance standards and processes related to clinical development and safety/pharmacovigilance. You will also be accountable for batch review and batch release for GMP.
Some of your primary responsibilities will include:
• Supports establishment of GxP Global Procedural Documents throughout all of the Roche development related organizational enterprises to ensure a consistent GxP process landscape for standards and processes and procedures related to clinical development and safety/pharmacovigilance which meet internal and external standards of regulatory compliance, as well as industry best practices and interpretations.
• Builds and maintains strong relationships with key business stakeholders
• Collaborates with a network of subject matter experts (SMEs) across the functional areas, supporting the Global Procedural Documents development.
The company is looking for someone who has:
• Bachelor’s degree or equivalent in scientific or quality-related field or equivalent combination of education, training, and experience
• Pharmaceutical experience- preferably in pharmaceutical development and working in a GxP regulated area
• Must have experience with batch release and batch review
• Demonstrated knowledge of GCP and/or GVP regulatory requirements, as well as analytical, organizational and planning skills
• Broad understanding of global expectations of Regulatory Authorities in the area of pharmaceutical development
This is an urgent role for the company so if you are interested in discussing this position further then please send your CV to Sabrina Deo at firstname.lastname@example.org