Compliance Assessor

To perform compliance review of analytical test methods, product specifications, and associated quality documentation to cGMP, Client internal standards and industry requirements; using standardized processes and procedures in support of compliance project. Manufacturing and Quality Compliance support would include but not be limited to; Review existing product/material analytical test methods and specifications, validation protocols and reports, stability protocols and reports, Periodic Quality Reviews, change controls, batch documentation and dossier. Support the resolution of issues as they occur in relation to testing during remediation implementation. Implement Analytical method improvement and validation to support cGMP. Product/Material Specification setting supported by stability data review; Protocol and Report review and approval; Update the Validation Master Plan with current data and any remedial work. Based on the regulatory variation strategy develop a manufacturing/analytical plan for the remediation work to ensure compliance. Request a quote for the works to be completed at the relevant manufacturing site and/or contract research organization (CRO) and agree a timescale for the works to be completed. Review and approve protocols and reports from the manufacturing site and/or CRO that control the required remedial work, ie process or analytical revalidation. Prepare Expert Statement to support regulatory submission. Support request for information requests which may arise on regulatory variation submission

SKILLS REQUIRED
Work Experience: A minimum of 5-8 years in a pharmaceutical quality testing or product development environment with a major emphasis on drug substance and multi-ingredient finished dose formulation testing. Experience with analytical method development, optimization, and validation. Experience with OTC ingredients used in cough, cold & allergy preparations and analgesics is a distinct advantage. Comprehensive understanding of quality compliance knowledge within EU and good understanding of GxP systems. A demonstrated business partner and ability to bring together multi-disciplined technical staff in order to problem-solve. Technical writing and documentation review abilities. Project management, communication and prioritization skills. Demonstrable experience of working with external manufacturers. Preferred raw material and product registration requirements.

QUALIFICATIONS REQUIRED
Educational - Minimum of Bachelors degree with a major in chemistry, chemical engineering or equivalent degree