Supply Operations Quality Specialist

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 and innovative.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality operations team. You will evaluate and review Pfizer’s clinical and commercial batches of pharmaceuticals. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the

relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

As a SOQ Specialist, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables.

Your innovative use of communication tools and techniques will facilitate explaining difficult issues and establishing consensus between teams.

How You Will Achieve It

• The key role of the SOQ Specialist is to establish and maintain an appropriate and sustainable Quality Management System and Quality Culture within the Pfizer Country Office (PCO) to ensure compliance with Pfizer and Regulatory Authority expectations.

• SOQ Specialist is the main point of contact for the investigation and resolution of all product quality issues detected or originating in the PCO and for interacting with the

relevant local stakeholders (such as Regulatory Affairs, Medical, Commercial, etc.) and Pfizer Global Supply (PGS) on such issues.

• SOQ Specialist monitors the product quality and compliance activities within the PCO, to ensure current regulatory expectations are met, and facilitate internal and regulatory GMP/GDP inspections.

Key Accountabilities

Resolution of Product Quality and Compliance Issues

Deviation Management

Investigates, together with appropriate local functions, deviations from Product Quality and Compliance requirements that occur within the responsibility of the PCO and agrees and tracks preventive/corrective actions. Local investigations may relate to product damage, artwork and labeling errors, counterfeits, temperature excursions during transport or issues with contract manufacturers or logistics service providers etc.

Customer Complaints Handling

Ensures that relevant customer complaints are dealt with effectively as the main responsibility.

Manages the intake of product quality complaints from the local market and forwards them to the appropriate global teams.

Tracks responses to product quality complaints. Develops and issues responses to complainants in a timely manner, if requested.

Provides input from quality perspective to Commercial Departments for the resolution of customer complaints related to distribution activities.

Notification to Management

Informs PGS Quality Operations Management of significant deviations and complaints.

Quality Management System

Ensures timely implementation of all applicable Product Quality SOPs (issued by SOQ) within the

PCO. Ensures that initial and continuous training programs are implemented and maintained for all relevant PCO colleagues. Monitors key quality performance indicators, evaluates and highlights any significant trends and identifies actions.

Inspections and Internal Audits

Supports the Responsible Person (RP) in the preparation and coordination of GMP/GDP Regulatory Agency inspections. Supports preparation and coordination of Regulatory Agency inspections internal Pfizer audits of Product Quality and Compliance (GMP/GDP) activities at the PCO. Works with local functions to define an appropriate action plan to address the inspection/audit

observation. Tracks the implementation of the identified actions within agreed timeframes.

Contracted Activities with GMP/GDP Impact

Approves any subcontracted activities which may have an impact on GMP/GDP: Develops, negotiates and maintains up to date Quality Agreements with GMP/GDP contractors, e.g. Logistics Service Providers (LSPs), relabeling/repackaging contractors. Oversees quality operations at contractors, which includes but is not limited to:

Oversight of Local Relabeling and Repackaging Operations

Ensures relabeling/repackaging contractor has been internally assessed and approved. Obtains regulatory approval of the relabeling/repackaging activity. Coordinates all activities related to Pfizer productsat the relabeling/repackaging contractor. Informs the releasing site of the

relabeling/repackaging activity.

Development and Maintenance of Consistent Quality Culture

Collects data and metrics on the PCO’s quality performance and communicates this to the Management of SOQ, PCO and RP. This involves a regular Management Quality Review process. Provides ongoing education on Quality to relevant PCO functional groups, to increase awareness and understanding of requirements and enhance the Quality Culture.

Suppliers’ and Customer Qualification

Ensures that suppliers and customers are qualified in accordance with GMP/GDP requirements. Provides local support, upon request, to the RP, for the customers’ qualification.

Personal development through active participation in Pfizer trainings, assignments, projects.

Active involvement in Pfizer internal and external meetings from commercial perspective. Identifies personal areas of improvement. Maintains a good work-lifebalance.

REQUIRED SKILL SET

Must-Have

• Bachelor's Degree in science or quality topics

• 0-3 years experience

• Proactive approach and strong critical thinking skills

• Excellent communication and interpersonal skills

• Good knowledge of Microsoft Office

• Strong negotiation and effective communication skills

• Self-motivated individual who is comfortable with working independently

• Able to lead and work effectively in cross-functional teams

Nice-to-Have

• Experience in Quality administered systems

• Knowledge of current Good Distribution Practices and the applicable GxP regulations and standards

• Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener

• Effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure

 
Work Location Assignment: Hybrid

Job Level: 40

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.