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SENIOR QUALITY ASSURANCE ANALYST

Indeed

Company

Job typeFull-time
Workplace typeOnsite
Experience level6 to 10 years
Education levelBachelor's Degree

Description

We are a Brazilian company with an international presence, whose DNA is innovation! At Biolab, we believe that diverse teams build stronger and more transformative results. **We value inclusion and diversity across all our positions**. Therefore, we encourage applications from people with disabilities and individuals of all identities, backgrounds, and origins**.** In the Analytical Development team, you will be responsible for developing and validating analytical methodologies for finished products, raw materials, cleaning, and processes. You will conduct stability studies, evaluate dissolution profiles, and qualify new raw material suppliers. You will also provide technical support to other departments, ensuring quality, regulatory compliance, and robustness of analytical processes. **WHAT WE EXPECT FROM YOU*** Bachelor's degree completed in Pharmacy, Chemistry, or related fields. * Solid experience in qualification of analytical equipment in the pharmaceutical industry (minimum 5 years). * Proficiency in instrumental analytical techniques (HPLC, UPLC, GC), calibration, and metrology. * In-depth knowledge of RDC 512/20 and RDC 658/22\. **KEY RESPONSIBILITIES FOR THIS POSITION*** Prepare and review qualification protocols and reports for equipment and utilities, based on current GMP regulations; * Perform qualification tests and update electronic records; * Prepare statistical trend analysis reports; * Collaborate in deviation investigations; * Schedule qualification services with third-party providers, especially for analytical equipment; * Follow\-up with internal and external suppliers. **Location****Employment Type****Work Model** Itapecerica da Serra, SP, BR Permanent CLT On-site

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Posted by

João Silva

Indeed · HR

Location

João Silva

Indeed · HR

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