Description
Job Summary:
Manage projects and processes for analytical method development/validation and stability studies in compliance with applicable regulations.
Key Highlights:
1. Experience in analytical development/validation/stability.
2. Proficiency in various pharmaceutical regulations.
3. Experience with chromatographic techniques and spectrophotometry.
**Requirements and Qualifications:**
Pharmacy degree;
**Knowledge:**
Proficiency in regulations RDC 964/25; RDC 166/17; RDC 318/19; RDC 31/2010, and other related regulations;
Intermediate English;
Quality tools;
**Responsibilities and Duties:**
Manage projects and processes for analytical development/validation of methods for active pharmaceutical ingredients and finished products, and stability studies, aiming to expand the company’s portfolio, maintain drug registrations, and comply with post-registration changes in accordance with applicable regulations.
**Skills**
Experience in analytical development/validation/stability; \* general chromatographic techniques (liquid, gas, and thin-layer chromatography), spectrophotometry (UV, IR, Raman, MS, optical spectrometric detectors, and mass analyzers), and volumetric techniques (potentiometric titration, acid-base, redox, complexation, precipitation);
Forced degradation studies and evaluation of organic, volatile organic, and inorganic impurities;
Laboratory management;
**Attitudes**
* Commitment to results;
* Self-development;
* Problem-solving ability;
* Resilience;
* Communication;
**Additional Information:**
Working hours: 8:00 AM to 6:00 PM
Location: Sabará