Pfizer

Associate MQA Downstream

Posted 12 Days Ago

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Vizag, Vishākhapatnam, Andhra Pradesh

Hybrid

Senior level

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical

We’re in relentless pursuit of breakthroughs that change patients’ lives.

The Role

The Associate MQA Downstream is responsible for ensuring compliance with cGMP standards in various pharmaceutical production processes, conducting inspections, and troubleshooting quality issues while collaborating with team leaders.

Summary Generated by Built In

Responsibilities:

Responsible for primary contact of quality on the floor, particularly in the Visual Inspection Training, Terminal sterilization, Visual Inspection and Packing areas of production and monitor processes for compliance to cGMP standards.
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. Associate or Sr. Team Leader
Review of Batch reports and Equipment audit trails
Perform Acceptable Quality level sampling, Inspection in VIDT and Batch record review and release
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. Associate or Sr. Team Leader
Review and assessment of equipment alarms and review of quarterly alarm trends
Report any non-compliance to the Sr. Associate or Sr. Team Leader
Trouble shooting in manufacturing area, which helps the organization 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

Here Is What You Need (Minimum Requirements)

BSC or B-Pharma / B-Tech with 5-7 years of experience
Experience working in a Pharmaceutical Company
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

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

Top Skills

Cgmp

Enterprise Resource Planning (Erp)

Quality Control Systems

What the Team is Saying

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The Company

HQ: New York, NY

121,990 Employees

Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.