Analytical Documentation Analyst

Description

Job Summary: Professional responsible for preparing and reviewing analytical documentation, supporting method development and compliance activities, with a focus on analytical validation. Key Highlights: 1. Participation in advanced analytical validation and method development. 2. Preparation and review of analytical dossiers and regulatory documents. 3. Support and monitoring of analytical compliance processes. **Analytical Documentation Analyst Position** **Work Location:** Hipolabor Unit II \- Anel Rodoviário Celso Mello Azevedo, 23220 – Eymard \- Belo Horizonte – MG CEP:31910\-585 **Working Hours:** 7:30 AM to 5:30 PM, Monday through Thursday; 7:30 AM to 4:30 PM on Fridays **Education:** Bachelor’s degree in Pharmacy, Chemical Engineering, or Chemistry **Qualifications:** Advanced analytical validation knowledge is mandatory. Technical English (reading and writing). Knowledge of quality tools and regulations is desirable. **Experience Required:** Experience in analytical validation and development routines is desirable. Experience in analytical documentation routines. Practical experience in document preparation. Practical experience using official compendia. Experience in an analytical laboratory (chromatographs and spectrophotometers) is desirable. **Microsoft Tools Proficiency:** Basic computer skills. **Job Responsibilities:** 1\. Conduct literature research, consult official compendia, and complete records for preparing and reviewing analytical development dossiers for finished products and raw materials, as well as analytical compliance documentation. 2\. Support analytical development analysts in preparing and verifying protocols and reports for analytical method development and validation. 3\. Prepare and reach technical consensus on analytical development techniques. 4\. Review the compliance matrix for APIs and registered products. 5\. Monitor receipt and critically evaluate theoretical prediction reports. 6\. Prepare risk analyses for implementing analytical methods for raw materials and products related to post-registration changes. 7\. Prepare comparative impurity profile reports for post-registration changes. 8\. Verify documents received from REBLAS laboratory (dissolution profiles, pharmaceutical equivalence, etc.) for regulatory processes. 9\. Initiate change control reports, if applicable. 10\. Prepare and review nitrosamine risk assessment reports; maintain the nitrosamine risk matrix updated; verify documentation received from third-party laboratories for confirmatory testing. 11\. Complete checklists for periodic product reports and forward them to the Quality Assurance department upon request. 12\. Conduct training sessions, if applicable. 13\. Consult and update the computerized nonconformance handling and change control system.