Spec, QA, Brazil

West Pharmaceutical Services; Diadema; Presencial; BRL 90 000 - 140 000; Tempo integral

Resumo da oferta

West Pharmaceutical Services in Diadema, SP is seeking a QA Specialist to support site quality systems and drive continuous improvement. You’ll manage quality records, support audits, and help ensure compliance with ISO, cGMP, and Anvisa guidelines.

This role acts as the interface with customers during audits and coordinates QA activities. The ideal candidate holds a bachelor’s degree in a relevant field, has GMP experience, and communicates effectively in English to support cross‑functional

Qualificações

• Bachelor’s degree in a relevant field.
• Experience with quality systems and cGMP.
• Knowledge of GMP/Anvisa guidelines is a plus.

Responsabilidades

• Lot/batch control and product release.
• Technical document control and SOPs.
• Audits (internal and external).
• Management of deviations and risk assessments.

Conhecimentos

Advanced English

GMP experience

Internal audits

External audits

Formação académica

Bachelor’s degree in pharmacy/chemistry/engineering/biology

Descrição da oferta de emprego

Spec, QA, Brazil

Location

Diadema, SP, BR

Department

Quality

Job Summary

In this role, you will support all quality systems and functions for the respective site. Assists in establishing systems to support the facility to drive continuous improvement and minimize the costs of non-conformance. Plans, schedules, executes, and communicates all items regarding quality issues, complaints, validations, and other projects to the QA Manager and/or other interested parties. Performs all duties associated with compliance-related items for ISO standards and cGMPs. This role is the interface between the customers and site for supporting audits.

Essential Duties and Responsibilities

• Lot/batch control and product release
• Technical document control (procedures, work instructions, technical specifications)
• Audits
• Knowledge of BPS and GMP (Anvisa’s Good Manufacturing Practices)
• Managing deviations
• Risk assessments / Risk analysis
• Change control

Education

• Bachelor's degree in Farmacy, chemistry, engineering, Biology, or technician in these areas

Preferred Knowledge, Skills and Abilities

• Advanced English
• Good Manufacturing pratices
• Experience or contact with the operations areas.
• Experience with Internal auditNice to Have:
• Experience with External Audit and Knowledge of Good Manufacturing Practices (GMP)