Mid-level Validation Analyst – Pharmaceutical Segment
Stefanini Brasil
full-time
Posted on:
Location Type: Hybrid
Location: Cotia • Brazil
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About the role
- Execute activities and projects as required by the department
- Serve as the interface between internal client areas and service providers
- Report incidents and lead problem resolution
- Initiate and manage Change Control
- Prepare and manage Non-Conformities and Deviations
- Actively participate in technical discussions and critical analyses
- Work in an organized, planned, and independent manner
- Maintain a critical perspective on pharmaceutical packaging processes
- Strong analytical skills and ability to interpret data
- Clear, concise, and assertive communication
Requirements
- University degree in Pharmacy or related fields
- Advanced English (reading, writing and technical communication)
- Experience with:
- - Process Validation
- - Cleaning Validation
- - Equipment Qualification
- - Validation of Computerized Systems (GxP)
- - Experience in the pharmaceutical industry, especially in production and packaging areas
- Validation of solid dosage processes and packaging lines
- Monitoring of production processes, handling non-conformities and risk assessment
- Preparation of protocols, reports, trend analyses and statistical evaluation of processes
- Cleaning validation (worst-case determination, acceptance criteria, sampling and statistical analysis)
- Equipment qualification and computerized systems validation (IQ, OQ, PQ, traceability matrix)
- Quality tools, Data Integrity, cGMP, 21 CFR Part 11 and current regulatory standards
- Good Documentation Practices and Good Manufacturing Practices (GMP)
Benefits
- Meal allowance or meal voucher
- Discounts on courses, university programs and language schools
- Stefanini Academy — platform with free, up-to-date online courses and certificates
- Mentoring
- Benefits club for medical consultations and examinations
- Health insurance
- Dental insurance
- Discount club with partner establishments
- Travel club
- Pet care partnership
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Process ValidationCleaning ValidationEquipment QualificationValidation of Computerized SystemsValidation of solid dosage processesMonitoring of production processesStatistical evaluation of processesGood Documentation PracticesGood Manufacturing PracticesData Integrity
Soft skills
Analytical skillsClear communicationConcise communicationAssertive communicationOrganizational skillsIndependent workCritical perspectiveProblem resolutionTechnical discussion participationPlanning