Aché Laboratórios

Senior Quality Assurance Analyst – Supplier Qualification

Aché Laboratórios

full-time

Posted on:

Location Type: Hybrid

Location: Guarulhos • Brazil

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Job Level

Senior

About the role

  • Plan and execute external supplier audits and internal audits according to the area's annual plan as the lead auditor, issuing reports and tracking the resulting corrective action plans. Maintain follow-up on validated action plans;
  • Maintain and monitor up-to-date supplier qualification documentation;
  • Maintain and update procedures and supporting documentation, aligned with best practices and organizational processes, within the applicable validity period;
  • Maintain and follow up on Good Manufacturing Practices (GMP) certification processes for manufacturers of pharmaceutical raw materials and finished products;
  • Represent the company in institutions for participation in technical working groups;
  • Represent the department during customer audits and regulatory agency inspections.

Requirements

  • Bachelor's degree in Pharmacy, Chemical Engineering, Food or Production Engineering, Industrial Chemistry, or related fields;
  • Postgraduate degree in areas related to Quality in the Pharmaceutical Industry;
  • Language: Fluent English;
  • Experience in the Pharmaceutical Industry and knowledge of national and international Good Manufacturing Practices regulations, such as ANVISA, ICH, PIC/S, EMA and US FDA;
  • Experience in supplier qualification routines across various scopes such as finished product and/or pharmaceutical raw materials and/or packaging materials and/or service providers and other supplier types;
  • Experience in internal audits and/or supplier audits;
  • Availability for national and international travel on a monthly basis when necessary – up to 50%.
  • Differential:
  • Knowledge of Risk Analysis tools (FMEA, GAMP, etc.);
  • Advanced knowledge of Microsoft Office suite and SAP systems;
  • Knowledge and experience in quality control laboratories, analytical development, or related areas;
  • Intermediate Spanish.
Benefits
  • Medical and dental assistance
  • Medications from Aché and Biosintética provided free of charge for you and your direct dependents
  • Preventive exams with no co-payment
  • On-site consultations and sample collection*
  • Wellhub (formerly Gympass)
  • “Estar Bem Aché” is our integrated health program, developed to support the mental, physical and social, financial, occupational and intellectual well-being of employees and their legal dependents
  • Support programs for pregnant and postpartum female employees and their spouses
  • Partnerships and agreements offering scholarships and educational discounts at various institutions
  • Results Participation Program (PPR)
  • Private pension plan (1:1 match)
  • On-site cafeteria and meal allowance
  • Transportation voucher, parking or company shuttle*
  • Childcare assistance or dedicated daycare at the Guarulhos site
  • Short Fridays exclusive to the Guarulhos site for administrative positions
  • Christmas gift
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
auditingsupplier qualificationGood Manufacturing PracticesRisk AnalysisFMEAGAMPquality controlanalytical developmentinternal auditssupplier audits
Soft Skills
communicationleadershiporganizational skills
Certifications
GMP certification