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. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. 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 Senior Associate, 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 in explaining difficult issues and establishing consensus between teams.

It is your dedication and hard work that will make it possible for Pfizer’s customers and patients to receive the medicines they need, when they need them.

How You Will Achieve It

Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
Monitor change management activities for contract manufacturers, packagers, and supply partners globally and manage routine complaints for the Drug Products and Drug Substances (APIs) manufactured.
Assure products supplied to our patients are manufactured, tested in accordance with c-GMPs, the registration file and any additional country specific requirements.
Participate in Virtual Site Operating Teams (VSOT) for ESQ managed contractors and for on Site Quality visits at the contractors.
Manage routine Customer Quality complaints for commercial Drug Products in PCOM and work in collaboration with the ESQ Contractor Quality.
Act as the lead for ensuring that the complaint investigation reports are appropriate and acceptable.
Ensure timely closure of complaints and alerting the appropriate colleagues as per our procedure and Standard Work guidance.
Support and Perform Lot Disposition for Biotech products in collaboration with other function

Qualifications

Must-Have

Bachelor's Degree
3+ years' experience
Fluent in English language (written and spoken)
Experience in Quality administered systems
Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards
Experience in Quality administered systems.
Excellent leadership, presentation, and oral/written communication skills.
Good organizational, negotiation skills and time management capability. Ability to build strong working relationships with leaders and support staff across multiple areas
Proactive approach and strong critical thinking skills
Must be able to work in a team environment within own team and interdepartmental teams
Excellent communication and interpersonal skills
Good working knowledge of Microsoft Excel and Word

Nice-to-Have

Master's degree and relevant pharmaceutical experience
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
Demonstrate customer relationship skills and ability to collaborate with teams.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control

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