Affiliate Quality Operations Analyst Sr / Analista Operações Qualidade Afiliada Sr. (Location: Guarulhos/SP) – São Paulo

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 innovative, always putting the patient first.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality team. You will actively support establishing and sustainable Product Quality System, focused on activities related to the Logistic Service Provider (LSP) and local product distribution in Brazil market under SOQ (Supply Operations Quality) leadership and work closely to key stakeholders: Global Supply Chain (GSC), Pfizer Global Supply Quality Operations (PGS QO), and the LSP itself. You will be a Technical Responsible, properly registered in the Local Pharmaceutical Council, in the Sanitary Surveillance Licenses, for Pfizer LSP (located in Guarulhos, SP), acting as Pfizer quality main point of contact for Regulatory Authorities at the LSP.

Note: position is 100% presential, to be based in Guarulhos, SP.

Local Contractor Quality Oversight

• Develop, negotiate and maintain up to date Quality Agreements with GMP/GDP contractors involved in manufacturing, repackaging or activities at Logistics Service Providers.
• Oversee quality operations at LSP, which includes but is not limited to:
• Contractor Assessment and Approval: ensure all GMP/GDP contractor have been formally assessed and approved.
• Deviation Management: evaluate the impact of all significant deviations affecting safety, identity, strength, purity & quality (SISPQ), generated at the contractor and agrees corrective actions. If necessary, request to initiate the “Notification to Management” process.
• Quality System Support: assess quality systems, review quality performance and agree action plans to ensure continuous improvement. Include quality reviews during Business Review Meeting, where existing.
• Issue and Review Metrics: Periodically assess the overall quality risk associated to the contractor. Act on adverse trends in order to improve contractor quality and compliance performance.
• Facilitates the Pfizer Research Quality Assurance (RQA) audit process at the contractor: support definition of appropriate action plans for improvement and follow-up and communicate action closures.

Resolution of Product Quality Compliance Issues

• Deviation Management: Investigates under SOQ leadership, together with appropriate local functions, deviations from Product Quality and Compliance requirements that occur within the responsibility of the Brazil PCO organization and agrees and tracks preventive/corrective actions until their completion. Local investigations may be related to temperature excursion, storage and outbound errors etc.

Notification to Management/Issue Escalation

• Support to evaluate the need of a Notification to Management/Issue Escalation and/or a notification to Regulatory Authorities.
• Attend Site Quality Review Teams (SQRT) meetings with SOQ Manager/LT. Provides SQRTs meetings minutes for issues originating under the responsibility of the PCO.
• Support colleagues in ensuring the local implementation of actions identified during Area Quality Review Team (AQRT) meetings, e.g. recalls, communication with Regulatory Agency, local corrective/preventive actions.

Market Action

• Supports any market action in Brazil according to the local regulations and Pfizer requirements.

Product Quality System

• Support timely implementation of all applicable Product Quality SOPs within the PCO (and at the LSP, as needed), evaluating its impact to SOQ activities.
• Attributes Product Quality SOPs training to all relevant PCO colleagues.
• Executes adjust/enhance to local systems and processes, when required.
• Evaluate new quality system/local regulatory requirements and adjust/enhance local systems and processes, when required.

Change Control

• Ensures that a Change Control is initiated for GxP activities under SOQ oversight, when necessary.
• Tracks the implementation of the identified actions within agreed timeframes with the involved areas.

Local Product Disposition

• Support the reception and management of Quarantine Alert Notices (QAN), depending on where the issue originated.

Inspections and Internal Audit

• Support colleagues (including from the contractor) in preparation and coordination of Regulatory Agency and internal Pfizer inspections of Product Quality and Compliance (GMP/GDP) activities at the PCO.
• Track the implementation of the identified actions within agreed timeframes under leadership of SOQ.

Here Is What You Need (Minimum Requirements)

• Bachelor’s Degree in Pharmacy
• Active registration at the Local Pharmaceutical Council (Conselho Regional de Farmácia – CRF)
• 4+ years’ experience
• 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
• Advanced English language communication verbal and written.

Bonus Points If You Have (Preferred Requirements)

• Master’s degree
• Relevant pharmaceutical experience on storage and distribution of cold chain products
• Experience with Electronic Quality Management Systems in pharmaceutical industry

Last date to apply for job: 17/04/2025

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