24 days old

[PGS] () () / Quality Operations (Tokyo) Quality Compliance (staff)

Pfizer
Tokyo
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**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 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.

+ Provide Quality Review and oversight of site cGXP documentation related to the operation of a vaccine 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.

+ Review and approval of validation documents Process, cleaning & method validation.

+ Develop annual product quality review plan.

+ Review and approve master batch records and executed batch records to assure compliance with regulatory standards and regulatory filing.



**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



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



\#LI-PFE
Posted: 2021-05-28 Expires: 2021-06-28
Sponsored by:
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[PGS] () () / Quality Operations (Tokyo) Quality Compliance (staff)

Pfizer
Tokyo

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