Senior State Filings Analyst at AIG, supporting regulatory product filings across personal insurance lines. Collaborating with multiple departments to ensure compliance with insurance regulations.
About the role
- Analista de Documentação Técnica Sênior at Synvia. Involves document management and regulatory compliance in the pharmaceutical industry.
Responsibilities
- Assist in preparing responses to sponsor monitoring, regulatory agencies, and internal Quality Assurance (QA) monitoring;
- Evaluate methods validated by the company and recommend adjustments according to RDC 27/2012, EMA, FDA, ICH-M10, RDC 166, ICH Q2/R2, RDC 31, RDC 318, DOQ-CGCRE-009, ISO 17025 and other applicable standards;
- Assist in closing action plans for non-conformance reports and opportunities for improvement;
- Draft and review Standard Operating Procedures to maintain good laboratory practices;
- Accompany sponsors during on-site monitoring visits;
- Control and evaluate Certificates of Analysis (CoA);
- Prepare and/or review analytical reports, analytical certificates and/or protocols, errata, amendments or protocol deviations, partial and full validation reports, supplementary reports, and stability reports in accordance with standards, legislation, official compendia and technical notes from ANVISA and national and international regulatory authorities;
- Finalize analytical study reports after sponsor approval and prepare the final electronic study file for archiving;
- Perform double-checks and critical reviews of documentation generated by the laboratory;
- Make protocols and reports available and conduct technical discussions with sponsors;
- Respond to internal monitoring/audits carried out by the Quality Assurance department related to analytical studies;
- Assist with technical responses to requests raised by competent authorities and/or sponsors;
- Register analytical studies in SINEB;
- Submit analytical reports in SINEB;
- Review Standard Operating Procedures relevant to the department;
- Archive research project documents according to internal procedures;
- Maintain the project database updated according to internal procedures;
- Request documents related to studies from other involved departments, when necessary;
- Assist in responses to regulatory inquiries;
- Support other analysts with technical questions and training;
- Attend internal and external audits in the absence of Leadership;
- Register, review and/or finalize studies in SINEB.
Requirements
- Bachelor’s degree in Biochemistry, Pharmacy, Chemistry, Biomedicine, Chemical Engineering, Biology or related fields;
- Intermediate English preferred;
- Proficiency with Microsoft Office;
- Knowledge of chemical analyses and good laboratory practices;
- Familiarity with analytical techniques (HPLC, UV/Vis, GC) and various physico-chemical assays;
- Experience in report review and preparation;
- Experience with PSA (forced degradation, impurities, extractables and leachables).
Benefits
- Transportation voucher;
- Parking (subject to availability);
- Health plan with no monthly fee for the employee, with co-pay for exams and consultations;
- Dental plan with monthly co-payment;
- Life insurance at no cost to the employee;
- Flexible meal/food allowance;
- Pharmacy discount program;
- Synvia Partnerships Club (educational institutions, language schools, leisure and cultural activities);
- SESC partnership;
- Physical wellness program – TotalPass;
- Day Off – Health Professional;
- Childcare assistance (according to internal policy).
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