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.

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.

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

Senior Quality Assurance Analyst – Supplier Qualification

Key skills