Ensure cGMP compliance for terminal sterilization, visual inspection, and packaging operations. Review eBRs, AMPS/recipe exceptions, batch reports, and equipment audit trails. Perform AQL sampling, start-up/end activities, process checks, walkthroughs, alarm trend reviews, and equipment breakdown/product quality assessments. Troubleshoot manufacturing issues, drive process simplification to reduce downtime, and support regulatory inspections.
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)
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:
- Responsible for ensuring operating state of cGMP compliance in Terminal Sterilization, Visual Inspection and Packaging operations.
- Maintain regulatory compliance in accordance with cGMP practices
- Ensure manufacturing policies and procedures conform to Pfizer standards.
- Knowledge and hands on experience in reviewing eBR and assessing the impact of AMPs exceptions with technical support/inputs from Sr. Team leader.
- Review of Batch reports, and Equipment audit trails
- Perform Acceptable Quality level sampling, Inspection and record the results in Batch records for all products.
- Perform batch start-up and end activities viz. sensor challenge tests, recipe review etc.
- Perform random process checks for Terminal Sterilization, Visual Inspection and Packaging.
- Perform Daily walkthroughs and report observations to the Sr. Team leader.
- Perform Equipment breakdown assessments w.r.t to Product Quality and patient safety with technical support/inputs from Sr. Team Leader.
- Review and assessment of equipment alarms and review of quarterly alarm trends.
- Should have trouble shooting abilities in manufacturing area, which helps the organization to develop, implement and achieve its mission, vision and values.
- Identify gaps and involve in Process and Procedure Simplification, thereby reduce downtime, and increase the Efficiency. AMPS Recipe review and validation of recipe.
- Experience in handling regulatory, corporate and internal auditors/ inspectors
Here Is What You Need (Minimum Requirements)
- B. Pharm, M. Pharm, MSc.
- 6-8 years of experience in Manufacturing Quality Assurance / Quality Assurance / Production of a pharmaceutical manufacturing facility.
- Fundamental knowledge of terminal sterilization process/ Visual Inspection/Packaging.Should be capable of handling regulatory inspections USFDA/MHRA/TGA, etc.,
- Ability to work effectively within own team and interdepartmental teams
- Good working knowledge of Microsoft Excel and Word
- Proactive approach to problem-solving
- Interpersonal Skills: Effective communication with all staff from different levels and builds constructive and effective relationship
- Acts Decisively: Makes decision in a timely manner based on available information
- Grows Self: Identify Individual development needs and create a plan and work towards achieving those objectives Critical thinking and Compliance mind set.
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
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
Pfizer Chennai, Tamil Nadu, IND Office
Chennai, India
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