<ul><li>Ensure compliance with regulatory guidelines (GMP, ICH, FDA) in analytical laboratories.</li><li>Review and approve analytical data, test methods, and validation reports.</li><li>Conduct audits of laboratory processes and documentation to maintain quality standards.</li><li>Investigate out-of-specification (OOS) and out-of-trend (OOT) results and implement corrective actions.</li><li>Collaborate with R&amp;D and QC teams to ensure analytical method validation and transfer.</li><li>Maintain and update standard operating procedures (SOPs) for laboratory practices.</li><li>Ensure proper documentation, data integrity, and adherence to ALCOA+ principles.</li><li>Support stability studies and review stability data for regulatory submissions.</li><li>Train laboratory personnel on analytical quality assurance best practices.</li></ul>

Analytical Quality Assurance