Development Analyst, Junior
Soulan Recursos Humanos
full-time
Posted on:
Location Type: Remote
Location: Brazil
Visit company websiteExplore more
Job Level
About the role
- Prepare change controls and review documents based on quality standards and applicable legislation, providing technical support across all company areas for the development of new products, portfolio maintenance and/or problem resolution
- Ensure all executed processes comply with current procedures, standards and regulations, reporting non-conformities using quality tools such as CAPAs, RIs and CMs when necessary
- Govern analytical development documentation through drafting, review and implementation, as well as updating documents in company systems according to established procedures
- Consolidate the rationale for analytical dossiers for registration and post-registration by performing technical reviews of documents such as methods, specifications, analytical validations, technical reports and stability reports, among others, prior to submission to the regulatory affairs area to ensure documentation quality
- Report detected quality non-conformities/deviations to management, providing relevant information for evaluation and decision making.
Requirements
- Education: Undergraduate in progress or completed in Pharmacy, Chemistry or related fields
- Knowledge: English (at least reading comprehension is a plus)
- Experience: Experience or knowledge in technical documentation within the pharmaceutical industry, preferably in Quality Assurance, Quality Control or Analytical Development; experience with change control, supporting the preparation, review and follow-up of documents related to process or method changes; experience or familiarity with review of analytical methods and critical evaluation of technical documentation; experience in management, review and organization of technical documents ensuring compliance with procedures and regulatory requirements; interface with different technical areas, contributing analyses, justifications and presentations of changes in committees or internal meetings.
Benefits
- Meal allowance
- Medical insurance
- Dental insurance
- Life insurance
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
technical documentationchange controlanalytical methodsquality assurancequality controlanalytical developmentregulatory compliancedocument reviewanalytical validationsstability reports
Soft Skills
communicationorganizational skillsanalytical skillsproblem resolutiondecision makingcollaborationpresentation skills