Analytical Documentation Analyst (TEMPORARY POSITION)

Description

Job Summary: Work as an Analytical Documentation Analyst, focusing on bibliographic research, dossier preparation, and technical support for analytical method development and validation. Key Highlights: 1. Focus on bibliographic research and dossier preparation. 2. Technical support in analytical method development and validation. 3. Experience in analytical documentation routines and official compendia. **Analytical Documentation Analyst Position (TEMPORARY POSITION)** **Work Location:** Hipolabor Unit II \- Anel Rodoviário Celso Mello Azevedo, 23220 – Eymard \- Belo Horizonte – MG CEP:31910\-585 **Working Hours:** 07:30 AM to 5:30 PM, Monday to Thursday; 07:30 AM to 4:30 PM on Fridays **Education Requirement:** 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 analytical laboratories (chromatographs and spectrophotometers) is desirable. **Microsoft Tools Proficiency:** Basic computer skills. **Job Responsibilities:** 1\. Conduct bibliographic 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\. Provide support to analytical development analysts in preparing and reviewing protocols and reports for analytical method development and validation. 3\. Prepare and reach technical consensus on analytical development methods. 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-approval changes. 7\. Prepare comparative impurity profile reports for post-approval changes. 8\. Review 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 up-to-date; review documentation received from third-party laboratories conducting 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 non-conformance handling and change control system.