Affiliate Quality Operations Analyst Pl

2 semanas atrás

São Paulo, São Paulo, Brasil Pfizer Tempo inteiro
Why Patients Need You


Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.

Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented.

What You Will Achieve

You will be a member of Pfizer's dedicated and highly effective quality team. You will serve as a primary contact for managing product defect complaints.

You will address and expedite product complaints in accordance with the company's complaint policy while ensuring compliance with regulatory agencies.

Based on the feedback received, you will be relied on to suggest modifications to the existing manufacturing and packaging processes.

You will maintain unified product defect investigation operating procedures and provide technical expertise to optimize the complaint processing systems. Your proactive problem solving approach will ensure that all complaints investigated and handled as per company policy.

How You Will Achieve It

Product Quality Complaints Management

  • Evaluate if the report represents a product quality complaint.
  • Perform follow up contact with the Intake group and/or the complainant to obtain the necessary and relevant information to process the complaint.
  • Intake and Triage of complaints from the local market(s), assign class and criticality to the product complaint and forward them to the appropriate investigating PGS /Contractor Site(s) via the global complaints management system.
  • Support the management of the complained samples, including the tracking of the samples.
  • Develop and issue response(s) to the complainant in a timely manner, when required.
  • Support the activities related to the management of the Offline Contractor Site(s) investigations in the global complaints management system (investigations conclusion in the system).
  • Sustain additional and complementary alignments and trainings with the involved team(s)/department(s).
Product Quality Incidents Management

  • Identify deviations from Product Quality and Compliance requirements that occur within the responsibility of the PCO(s) organization and initiate the incident ́s investigation.
Product Quality System

  • Support timely implementation of all applicable Product Quality SOPs within the PCO(s) and its impact in the SCQ activities.
  • Support adjustment/enhancement to local systems and processes, when required.

Qualifications:

Must-Have

  • Bachelor ́s Degree in Biologics Sciences or equivalent (Pharmacy, Biochemistry, etc.)
  • Minimum 23 years working in pharmaceutical or related industry, preferably in Quality Operations and/or in activities related to Product Quality Complaints (Medical Information, Pharmacovigilance, etc.) and/or Product Disposition.
  • Intermediary/advanced English and Spanish language communication verbal and written.
  • Appropriate technical experience to manage expectations
  • Knowledge of the regulatory GDP/GMP compliance issues relating to manufacturing and distribution of medicinal products
  • Excellent organization skills and the ability to manage multiple priorities
  • Good collaboration, communication and interpersonal skills with local, regional and global colleagues
  • Proficiency in using System Application and Products, Microsoft Word, Excel, Power Point, Visio
Nice-to-Have

  • Master's degree
  • Relevant pharmaceutical experience
  • Experience with Electronic Quality Management Systems in pharmaceutical industry

Work Location Assignment:
Flexible

Fixed term - 7 months

Último dia para se aplicar à vaga: 10/3/2023


A Pfizer é uma das maiores empresas biofarmacêuticas de inovação do mundo e um dos valores da companhia é Equidade.

Esta é uma oportunidade igualitária para todas as pessoas independentemente da raça, origem, gênero, orientação sexual, idade, presença de deficiência, estado civil, religião ou crença, nos termos da lei.

Valorizamos a diversidade e inclusão, e buscamos um ambiente de trabalho cada vez mais plural, justo e equânime.

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