Senior Analytical Development Reviewer

Reporting to Head of Analytical Development/Head of Quality, the Successful Candidate will be Responsible for Reviewing and Approving Analytical Development Documentation, Ensuring Compliance with Current Regulatory Expectations, GMP

Requirements and Data Integrity Principles, whilst Supporting Global Product Registrations

ROLE, (Includes)

• Review and Approve Analytical Method Development Protocols and Reports
• Review Analytical Method Validation, Verification and Method Transfer Documentation
• Review Raw Analytical Data, Calculations, Chromatograms and Technical Reports for Accuracy and Compliance.
• Ensure Analytical Methods Comply with ICH Guidelines and Pharmacopeial

Requirements

• Review Forced Degradation Studies and Stability-Indicating Methods
• Review Dissolution Method Development and Validation Studies
• Support Analytical Investigations, Including OOS, OOT, Deviations and CAPA’s
• Review Analytical Specifications, SOP’s and Technical Documentation
• Support Regulatory Submissions and Responses to MHRA, FDA and Customer Queries
• Ensure Compliance with GMP, ALCOA+ Data Integrity Principles and Company Procedures
• Provide Scientific Guidance to Analytical Development Scientists
• Support Technology Transfer Activities into the Quality Control Laboratories
• Participate in Internal Audits, Customer Audits and Regulatory Inspections

REQUIRED

• MSc or MPharm in Analytical Chemistry, Pharmaceutical Chemistry, Pharmaceutical Analysis or Related Scientific Discipline
• Minimum 5 Years' Experience in Pharmaceutical Analytical Development
• Extensive Involvement in MHRA/FDA Regulated Pharmaceutical Manufacturing Environment
• Hands-On Experience Reviewing Analytical Method Development and Validation Documentation
• Strong HPLC/Chromatography Background and Experience of a Wide Range of Analytical Instruments/Apparatus and Techniques/Procedures
• Experience Supporting Regulatory Submissions and Inspections
• Foundation of Supporting Analytical Method Development and Validation
• Strong Understanding of ICH Guidelines and Regulatory Expectations
• Hands-On Experience investigating OOS, OOT, Deviations and CAPA’s
• Solid Understanding of Technology Transfer and Lifecycle Management Activities
• Experience Reviewing Stability Studies
• Contract Manufacturing Experience of Solid Oral Dosage Forms, (Desirable)