Job Description

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\xe2\x80\x99s dedicated and highly effective quality assurance team. You will drive quality culture and promote GMP compliance to the site. You will ensure site compliance to Pfizer Quality Standard and ICH guideline. You will provide oversight to site GMP operations to ensure product produced in compliance with Pfizer Quality Standards.

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. You will collaborate with cross functional teams to improve quality systems. It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Suggest improvements and conduct continuous improvement activities.
• Independently assess a wide range of Change Control activities to determine potential Quality and Operational Good Manufacturing Practices {also cGMP} impacts.
• Investigate, document Quality Assurance related deviations and escalate issues as appropriate to the Quality Assurance Lead in a timely manner.
• Maintain regulatory compliance in accordance with current Good Manufacturing Practices {part of GxP} practices.
• Improve quality assurance systems, as necessary.
• Maintain current quality tracking systems and the quality metrics to proactively identify trends and atypical observations.
• Provide Quality Review and oversight of site cGXP documentation related to the operation of API manufacturing facility/laboratory to ensure compliance with global regulatory agencies and Pfizer quality standards.
• Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives.
• Develop annual product quality review plan and report

Qualifications

Must-Have

• Bachelor\'s Degree
• 3+ years\' experience
• Experience in Quality administered systems
• Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards
• 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

Work Location Assignment: Flexible

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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Pfizer