Quality Assurance Associate

Job Description

Why Patients Need YouEverything 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 AchieveYou 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 an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.It is your hard work and commitment 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 complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Ensure proper system in place for the investigation of deviations detected in product quality prior to the release of the batches in compliance with Pfizer and regulatory standards.
• Review finished product customer complaints according to Pfizer and regulatory requirements.
• Focus on Safety and GMP Compliance as operational priorities and on the principle and practices of good data management (ALCOA).
• Accurately communicate supply, operational needs or Quality Operations (QO) perspectives and escalate issues with potential market, regulatory or stability impact.
• Ensure an active daily presence in the GMP work area to observe the work activity and site practices.
• Provide Real Time Quality impact assessments and decisions on product issues, independently.
• Maintain inspection readiness, support inspections from regulatory agencies & customers.
• Participate in Green/Black belt projects, IMeX projects, Corrective Action / Preventive Action Effectiveness, etc. as appropriate.
• Assist and support the manufacturing/packaging staff in detecting and solving compliance errors in real time during manufacturing and packaging operations.
• Help to define appropriate action plans for improvement and follow-up and communicate action closures.
• Contribute to the redaction and review documents including SOP?s (Standard Operating Procedures), annual reviews, etc.
• Participate in Quality Risk Management (QRM) assessments that gain approval through Site and Area Quality Operations (QO) Management.

QualificationsMust-Have

• Bachelors Degree
• 2+ years experience in pharmaceutical industry
• Sound knowledge of current Good Manufacturing Practices {part of GxP}
• Ability to work in a team environment and interdepartmental teams
• Effective written and oral communication skills
• Good level of English

Nice-to-Have

• Experience of managing deviations

Work Location Assignment: On PremisePfizer 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

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