QA SME Analytical

Provide technical guidance on analytical method development, validation and transfer. Review and approve analytical protocols, reports and methods. Ensure analytical testing meets GMP, ICH, FDA, EMA and pharmacopeial requirements. Support investigations, including OOS/OOT results and data integrity issues. Provide expertise in chromatography and analytical techniques such as HPLC, GC, dissolution and spectroscopy. Oversee stability studies and ensure they meet regulatory requirements. Conduct risk assessments for analytical methods and processes. Support QC, QA and Manufacturing with analytical matters. Identify and implement improvements to analytical processes and performance. Support regulatory submissions, audits and inspections. Qualification: Diploma or Degree in Chemistry or a related scientific field. Experience: 10+ years' experience in analytical laboratory roles. Strong experience in analytical method development, validation and transfer. Experience with chromatography, particularly HPLC and GC. Good knowledge of pharmacopeial requirements and pharmaceutical regulations.