Complaints Full Associate / Analista de Reclamações de Qualidade PL

Use Your Power for Purpose

Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. 

What You Will Achieve

In this role, you will:

Support the intake, triage and documentation of Product Quality Complaints (PQCs), ensuring accurate and timely processing in compliance with global procedures and regulatory requirements. The Full Associate handles more complex tasks with greater autonomy, interacts with Boards of Health, contributes to investigations and system improvements and supports compliance readiness, while escalating final decisions to the leadership.

Job Responsibilities:

·       Obtain and document the complaint information (as applicable).

·       Translate the complaint description to English, if initially captured in a different language.

·       Confirm the validity of the complaint and record all valid complaints within the Global Complaint Database, when applicable, according to the due dates established.

·       Classify and prioritize the complaint.

·       Determine the site assignments and whether further investigation is recommended.

·       Obtain the lot number, if initially unknown.

·       Request the return of the complaint sample (where available) and support the sample management, including the tracking of the samples.

·       Send any initial correspondence to the complainant, if required.

·       Issue related complaint notifications (as applicable).

·       Forward the complaint to the Lead Site according to the determined timeframes.

·       Record any follow-up information received within the complaint records and communicated to the investigating site(s), DSU and DCHU according to the established timeframes.

·       Sustain additional and complementary alignments and training with the involved team(s)/department(s). 

·       For complaints received via local regulatory Body, interact and provide a final response letter as applicable.

·       Support / elaborate final responses for complaints as applicable.

·       Support / perform department metrics elaboration and PQC monthly audit by responding and contributing with detailed/ additional information as requested.

·       Support / perform the review of documents, procedures and/or records as requested / applicable.

·       Ensure timely training and implementation of applicable SOPs.

·       Support system improvements focused on simplification and efficiency and contribute to updates and enhancements of local quality processes.

·       Promote data integrity across all GMP/GDP records.

·       Assist in audit and inspection readiness.

• Identify and report unplanned incidents, support deviation assessments and investigations.

• Support on tasks related to the QMS, such as: Quality Agreement, ChangeControl, Nonconformance Management, Document Management, Personnel & Training Management.

Here Is What You Need (Minimum Requirements)

• Bachelor´s Degree in Biologics Sciences or equivalent (Pharmacy, Biochemistry, etc.)

• Minimum 4 years working in pharmaceutical or related industry, preferably in Quality Operations and/or in activities related to Product Quality Complaints (Medical Information, Pharmacovigilance, etc.).

• Advanced English and intermediate Spanish language communication verbal and written.

Computer and systems literate. 

• Effective communication skills. 

Good communication with internal and external customers. 

Self-motivated. 

• Respond to changes with agility and have good discernment for prioritization.

Bonus Points If You Have (Preferred Requirements)

•

• Knowledge of complaint processing systems and the ability to suggest modifications to enhance quality

• Ability to analyze and interpret data to identify trends and communicate findings

• Excellent judgment and decision-making skills

• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

 
Last date to apply for job: February 27, 2026

EEO (Equal Employment Opportunity) & Employment Eligibility 

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.

Quality Assurance and Control