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West Pharmaceutical Services

Spec, QA, Brazil

West Pharmaceutical Services Diadema, São Paulo, Brazil

Pharmaceutical Manufacturing · 5,001-10,000 employees

20 h ago Closes in 7d
qa Mid (2-5 yrs) Full-time Brazil
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About the role

This role supports quality systems, compliance, and continuous improvement initiatives at the facility. Responsibilities include managing batch control, technical documentation, audits, and serving as the primary interface between customers and the site.

What they look for

Quality systems ISO standards cGMP Anvisa Batch control Product release Technical document control Audits BPS Deviations management Risk assessment Change control Internal audit External audit Operations support

Requirements

Candidates must hold a bachelor's degree in Pharmacy, Chemistry, Engineering, or Biology, or possess a relevant technical certification. Proficiency in English and knowledge of GMP and Anvisa regulations are required.

Full description

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 audit

Nice to Have:

• Experience with External Audit and Knowledge of Good Manufacturing Practices (GMP)

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