Job Description
- 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.
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