Evaluate and approve commercial drug batches for cGMP/GxP compliance; perform sampling and statistical process control; investigate and document QA deviations; assess change controls; provide quality review of site documentation and contribute to projects.
Use Your Power for Purpose
Every day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.
What You Will Achieve
In this role, you will:
Here Is What You Need (Minimum Requirements)
Bonus Points If You Have (Preferred Requirements)
Work Location Assignment: On Premise
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
Every day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.
What You Will Achieve
In this role, you will:
- Evaluate and review commercial drug batches to ensure compliance with established specifications.
- Conduct rigorous sampling and statistical process control procedures to identify deviations from standards.
- Approve investigations and change control activities to maintain compliance with configuration management policies.
- Contribute to moderately complex projects, managing time effectively and developing short-term work plans.
- Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts.
- Investigate and document Quality Assurance deviations, escalating issues to the Quality Assurance Lead as needed.
- Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards.
Here Is What You Need (Minimum Requirements)
- Bachelor of Sciences/ Pharmacy with 8+ years of experience or Masters degree with 6+ years of experience with relevant experience in Manufacturing upstream/ downstream operations.
- Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards
- Strong critical thinking skills
- Ability to work effectively within own team and interdepartmental teams
- Good working knowledge of Microsoft Excel and Word
- Proactive approach to problem-solving
Bonus Points If You Have (Preferred Requirements)
- Experience in quality administered systems
- Strong organizational skills and attention to detail
- Experience with regulatory compliance and documentation
- Ability to mentor and review the work of other colleagues
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
Work Location Assignment: On Premise
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
Similar Jobs at Pfizer
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
As a Graduate Apprentice, you will support organizational operations, manage administrative tasks, assist marketing campaigns, and contribute to process improvements while fostering professional growth.
Top Skills:
Ai ToolsChatgptDigital PlatformsMicrosoft Copilot
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
The role involves managing quality assurance processes, reviewing validation protocols, ensuring compliance with GMP guidelines, and overseeing technology transfers and investigations.
Top Skills:
ExcelMicrosoft Word
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Lead and review microbiology method validation/verification and quality activities including BET and sterility testing, equipment qualification, change control, risk assessments, investigations, regulatory/GMP compliance, documentation review, and cross-functional mentoring to support product lifecycle and inspections.
Top Skills:
Bacterial Endotoxin Test (Gel Clot)Bp Compendial StandardsDirect Inoculation)Environmental MonitoringEpGmpGrowth Promotion TestingHvac SystemsIch Q2 (R1/R2)Ich Q9IncubatorsIsolatorsJpKinetic ChromogenicKinetic TurbidimetricMcs ReaderMedia PreparationMicrobial Identification SystemsMicroscopic Particulate CountSterility Testing (Membrane FiltrationUspWater System Qualification
What you need to know about the Kolkata Tech Scene
When considering the industries shaping India's tech scene, gaming might not immediately come to mind. However, in the last decade, increased internet usage and greater access to mobile devices have catapulted the industry to new heights, with Kolkata-based companies like Virtualinfocom, Red Apple Technologies and Digitoonz, at the forefront, driving the design and animation of new gaming titles for players.
