Analista de Controle e Qualidade Sr

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**We are searching the best talent for SENIOR QUALITY CONTROL ANALYST (TEMPORARY 12 MONTHS) to be in **São José dos Campos, Brazil.**

**Purpose**:
Senior Quality Control Analyst responsible for method evaluation (NPI, product release), supports strategy to orchestrate changes needed with the mínimal impact to the business (schedules definition, method transfer to new lab and alignment with QA and QC team)

**You will be responsible for**:
Key responsibilities include, but are not limited to the ones listed below as per Project Nunki assumptions:

- Document changes controls and risk assessment elaboration as needed
- Ensure compliance with applicable regulations, standards and procedures
- Ensure compliance with Data Integrity
- Support investigations for non-conformances for method transfers
- Elaborate documents at TRU according to methods transfers (protocol and reports)
- Perform related to the transfer of analytical methodologies from the current lab to the new lab and connection with DPDS/COE to any support on transfer activities
- Perform the transfer timeline of execution
- Support other analysts of the project
- Perform deep dive in the methods to support equipment team
- Post registration changes and variation (evaluation and execution)
- Cancellation of Registration and titularity transfer
- Elaboration and review of technical documentation. (PATE, HMP, Technical Justification, Change Control Assessment and Risk Documentation).
- Conduct activities of artwork, packaging, and label updates.
- Manage and assess information in general regulatory systems (Grail, Insight, Trackwise, Webtcards and TruVault).
- Update/ obsolete documents, procedures, and specifications.

**Qualifications**:
**Qualifications and requirements**:

- Degree in Pharmacy, Biology, Biochemistry, Microbiology, Chemistry or related areas;
- Requires 3-5 years of related field experience at university/college or medical device, pharmaceutical or cosmetic industry;
- Advanced knowledge/experience in requirements, policies, and guidelines regulatory.
- Advanced knowledge in method transfer;
- Robust knowledge and understanding of current Good Manufacturing Practices (cGMP) for Pharmaceutical products and ability to identify gaps in processes or systems;
- Ability to positively influence peers;
- Analytical and strategic thinker;
- Be able to develop and maintain relationships/partnerships and to work collaboratively both internally and externally;
- Must work well in a dynamic environment, work independently, and handle multiple tasks/demands;
- Good written and verbal communication skills;
- Advanced English is mandatory;
- Will be full-time based in São José dos Campos, SP, Brazil.