Job Description:
• Compile, review, and finalize all quality control sections of regulatory dossiers in country-specific formats for Central American markets in compliance with RTCA regulations.
• Perform detailed line-by-line review of QC documents including specifications, certificates of analysis (COAs), analytical methods, and validation reports.
• Verify accuracy, consistency, and scientific correctness of analytical data based on practical QC laboratory experience.
• Execute formatting, pagination, indexing, cross-referencing, and version control of QC documents within the dossier.
• Conduct gap analysis of QC documentation and identify missing, inconsistent, or non-compliant data prior to dossier finalization.
• Review and validate analytical methods, test parameters, system suitability criteria, acceptance limits, and results for regulatory compliance.
• Ensure all QC documents comply with RTCA requirements and country-specific regulatory expectations in Central America.
• Review regulatory queries, deficiency letters, and observations related to QC sections and identify technical gaps.
• Prepare and finalize accurate responses to QC-related regulatory queries with complete supporting analytical justification.
• Maintain controlled documentation, archival systems, and traceability of all QC-related regulatory records and dossier versions.
Requirements:
• Bachelor’s or Master’s degree in Pharmacy, Analytical Chemistry, or related life sciences discipline (mandatory).
• 3–6 years of hands-on experience in Quality Control for finished pharmaceutical formulations (mandatory).
• Candidate must have practical experience in conducting or reviewing analytical testing (e.g., HPLC, dissolution, assay, related substances, etc.) and should be currently or previously involved in laboratory analysis activities.
• Strong understanding of QC documentation including specifications, COAs, analytical methods, method validation reports, and stability data.
• Working knowledge of RTCA regulations and Central American dossier requirements (preferred, but strong QC background is mandatory).
Benefits:
• Hands-on role combining QC technical expertise with regulatory dossier execution.
• Exposure to RTCA regulatory framework and Central American markets.
• Structured, execution-driven environment with clear accountability.
• Opportunity to transition from QC laboratory to regulatory domain with strong technical grounding.
• Career growth aligned with regulatory and quality systems integration.