Description
We are a Brazilian company with international presence, whose DNA is innovation! At Biolab, we believe that diverse teams build stronger and more transformative results. **We value inclusion and diversity in all our positions**. Therefore, we encourage applications from people with disabilities and from 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:**
Completed undergraduate degree in Pharmacy or Chemistry
Availability for a 100% on-site work model (Itapecerica)
Strong communication skills, interpersonal relationship abilities, and problem-solving capacity
Knowledge of Liquid and Gas Chromatography, ICP (desirable), GLP, RDC 31/10; RDC 53/15; RDC 73/16; RDC 166/17; RDC 318/19
**BELOW ARE THE MAIN RESPONSIBILITIES OF THIS POSITION:**
* Perform analytical validation analyses on products and raw materials, as directed by senior/lead analysts and coordination.
* Conduct stability studies (accelerated, long-term, in-use, and photostability) for pharmaceuticals, cosmetics, and food products.
* Carry out forced degradation and dissolution profile studies, including preparation of protocols and reports in accordance with RDC 31 and RDC 53 (ANVISA).
* Develop, validate, and transfer analytical methods for products, raw materials, and cleaning.
* Prepare and review technical documents such as: certificates of analysis, analytical methods, SOPs, calculation sheets, protocols, and technical reports.
* Perform statistical and trend analyses of stability studies.
* Prepare solutions, reagents, and materials required for routine analytical work.
* Manage, incubate, and monitor samples in stability chambers.
* Support the review, verification, and approval of stability protocols and studies.
* Investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) results, with leadership support.
* Initiate, track, and resolve analytical deviations, CAPAs, and NCs, supporting implementation of corrective actions.
* Support qualification, calibration, and verification processes for laboratory equipment.
* Ensure laboratory organization, material expiry control, and maintenance of appropriate equipment and environmental conditions.
* Comply with quality, safety, environmental, and good laboratory practice standards.
* Support procurement processes, follow-up of reagents, standards, and consumables, as well as invoice entry and tracking in the system.
* Provide technical support to pharmaceutical development and technical documentation departments.
* Guide junior analysts, assistants, aides, and interns in performing laboratory activities.
* Participate in regulatory inspections and audits alongside coordination and management.
**Location**
Itapecerica da Serra, SP, BR