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Job Description

Location: São José dos Campos

In this position the analyst will be assigned to the Analytical Development Laboratories team focused on the Introduction of New Products. He/She will be responsible for all processes related to analytical validation and/or transfer for launching new products in the Brazilian market as well as for post-registration changes. This includes preparing and managing project delivery schedules creating reviewing and executing validation or transfer protocols and verifying analytical data. The analyst will conduct critical technical evaluations in accordance with regulatory quality and global compliance requirements and will oversee the purchase and tracking of materials and equipment necessary for project execution.

Responsibilities:

- Conduct validation analyses and analytical transfers for chemical and/or microbiological laboratories of finished products.

- Design and review analytical protocols and reports.

- Execute investigations and evaluate non-conforming results.

- Manage analytical transfer projects for the introduction of new products technologies and processes.

- Participate in global meetings to discuss and position project design and execution stages.

- Draft and review standard operating procedures.

- Prepare and assess change controls.

Required Experience and Skills:

- Experience in the pharmaceutical industry.

- Experience in analytical laboratory with expertise in key techniques (IV UV GC HPLC UPLC and use of Empower software).

- Experience in analytical methodology validation and/or analytical transfer.

- Knowledge of major current legislation.

- Advanced English.

Desired Qualifications:

- Experience in analyses and validation for microbiological methodology.

Required Skills:

Preferred Skills: