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Senior Quality Assurance Analyst – Affirmative Action Position for Black, Brown, and Persons with Disabilities
Daiichi Sankyo Brasil Ltda. Prepare, review, and approve Standard Operating Procedures and other Quality Assurance documents in compliance with Good Manufacturing Practices .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Assurance processes, including the preparation and approval of Standard Operating Procedures in compliance with Good Manufacturing Practices. Proficient in managing documentation, conducting audits, and evaluating manufacturing processes within the pharmaceutical industry.
Highest-signal resume keywords
Good Manufacturing Practices ComplianceQuality Assurance Documentation ManagementBatch Documentation EvaluationInternal and External AuditsPharmaceutical Industry Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Standard Operating Procedures PreparationQuality Deviation InvestigationAnalytical Specifications ManagementProduct Inspection DocumentationChange Control Management
Tools & Technologies
Microsoft Office
Certifications & Qualifications
Bachelor’s Degree in PharmacyActive Professional Registration with CRF
Industry Keywords
Pharmaceutical IndustryQuality AssuranceManufacturing ProcessesBatch ReprocessingMarket Complaints Management
About the role
Key responsibilities & impact- Prepare, review, and approve Standard Operating Procedures and other Quality Assurance documents in compliance with Good Manufacturing Practices
- Manage documents such as procedures, batch documentation, analytical specifications, and analytical methods
- Correct and approve master documents for manufacturing and packaging orders
- Evaluate manufacturing, packaging, and production orders, as well as certificates of analysis, before deciding whether to approve or reject the finished product
- Approve or reject bulk and/or finished product batches after evaluating batch documentation
- Support the documentation of batch reprocessing and product inspections
- Manage and participate in quality deviation investigations and change controls
- Receive, evaluate, register, route, and respond to market complaints
- Complete the Good Manufacturing Practices training program
- Compile and evaluate data on manufactured products and prepare periodic product reviews
- Monitor production batches, the development of new products and materials, and equipment qualification
- Monitor the implementation of changes and the execution of actions
- Monitor preventive and corrective actions related to deviations, audits, and improvements
- Prepare annual schedules for internal and external audits
- Conduct and/or monitor internal and external audits, prepare reports, and distribute them to the relevant departments or companies
Requirements
What you’ll need- Bachelor’s degree in Pharmacy
- Experience in the pharmaceutical or related industry
- Intermediate English proficiency
- Proficiency in Microsoft Office
- Active professional registration with the Regional Pharmacy Council (CRF)
- Affirmative action position for Black, Brown, and Persons with Disabilities
Benefits
Comp & perks- Temporary position covering maternity leave
- Hybrid work model