Role at a glance
- Job function
-
Manufacturing & Skilled Trades Quality Assurance & Quality Control
- Salary
- Not Disclosed
- Location
- China, Shanghai, Shanghai
- Employment
- Full-time
- Experience
- Bachelor's degree with any years of experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience
- Education
- Bachelor's degree with any years of experience, or an Associate's degree with 4 years of relevant experience
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Role Summary
This Supply Operation Quality Associate role supports quality assurance for clinical and commercial drug batches, covering batch review, deviations, change control, and inspection readiness. The role involves ensuring product and process documents meet established specifications and that manufacturing and packaging records conform to policy and cGMP standards.
What You'll Do
- Evaluate and review clinical and commercial drug batches to ensure quality.
- Ensure product and process documents meet established specifications through rigorous sampling and statistical process control.
- Identify and address deviations from manufacturing and packaging standards.
- Approve investigations and oversee change control activities to maintain compliance with configuration management policies.
- Contribute to project tasks and milestones, organizing work to meet deadlines.
- Ensure manufacturing and packaging records conform to Pfizer policy and cGMP standards.
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
Bachelor's degree or equivalent experience in the pharmaceutical industry with knowledge of cGMP and quality systems.
Required
- Bachelor's degree with any years of experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma...
- Experience in the pharmaceutical industry and Quality administered systems
- Sound knowledge of current Good Manufacturing Practices (part of GxP)
- Ability to work effectively in a team environment, both within one's own team and interdepartmental teams
- Effective written and oral communication skills
Preferred
- Experience at a manufacturing site.
- Managing and writing deviations
- Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis...
- Strong problem-solving skills
- Ability to work independently and as part of a team
- Excellent time management and multitasking abilities
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and...
Original job description
Content provided by the employer
Original job description
Content provided by the employer
Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our mission to improve patient outcomes.
What You Will Achieve
In this role, you will:
- Evaluate and review clinical and commercial drug batches to ensure quality.
- Ensure product and process documents meet established specifications through rigorous sampling and statistical process control.
- Identify and address deviations from manufacturing and packaging standards.
- Approve investigations and oversee change control activities to maintain compliance with configuration management policies.
- Contribute to project tasks and milestones, organizing work to meet deadlines.
- Learn and apply basic team effectiveness skills within the immediate work team.
- Make decisions within limited options to resolve basic problems under supervisor's direction.
- Ensure manufacturing and packaging records conform to Pfizer policy and cGMP standards.
- Maintain inspection readiness, support regulatory and customer inspections, and improve quality assurance systems.
- Assist manufacturing/packaging staff in real-time compliance error detection and resolution, and lead or participate in Quality Risk Management assessments.
Here Is What You Need (Minimum Requirements)
- Bachelor's degree with any years of experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience
- Experience in the pharmaceutical industry and Quality administered systems
- Sound knowledge of current Good Manufacturing Practices (part of GxP)
- Ability to work effectively in a team environment, both within one's own team and interdepartmental teams
- Effective written and oral communication skills
Bonus Points If You Have (Preferred Requirements)
- Experience at a manufacturing site.
- Managing and writing deviations
- Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management
- Strong problem-solving skills
- Ability to work independently and as part of a team
- Excellent time management and multitasking abilities
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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.
Quality Assurance and Control
About the company
Pfizer
Large Enterprise
Pfizer is a global biopharmaceutical company dedicated to the discovery, development, and manufacturing of innovative healthcare solutions. With a strong focus on improving lives through medications and vaccines, Pfizer has played a significant role in addressing various health challenges, including infectious diseases, chronic illnesses, and rare conditions. The company emphasizes research-driven approaches and collaborative efforts in its mission to enhance global health and empower patients through cutting-edge science and technology. Through its commitment to high standards of safety and efficacy, Pfizer continues to shape the future of medicine.