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The Role
The MQA Downstream Associate Manager oversees compliance with cGMP standards in Terminal Sterilization, Visual Inspection, and Packaging operations. Responsibilities include maintaining regulatory compliance, reviewing batch reports, conducting inspections, and supporting equipment assessments.
Summary Generated by Built In
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.
Role Summary for Associate Manager:
The MQA Downstream Associate Manager is responsible for primary contact of quality on the floor, Particularly in the 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.
Responsibilities:
MES quality 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.
Experience:
B. Pharm, M. Pharm, MSc.
6-8 years of experience in Manufacturing Quality Assurance / Quality Assurance / Production of a pharmaceutical manufacturing facility.
Shall able to work in the shifts.
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.
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.
Role Summary for Associate Manager:
The MQA Downstream Associate Manager is responsible for primary contact of quality on the floor, Particularly in the 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.
Responsibilities:
MES quality 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.
Experience:
B. Pharm, M. Pharm, MSc.
6-8 years of experience in Manufacturing Quality Assurance / Quality Assurance / Production of a pharmaceutical manufacturing facility.
Shall able to work in the shifts.
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.
Quality Assurance and Control
Skills Required
- B. Pharm, M. Pharm, MSc
- 6-8 years of experience in Manufacturing Quality Assurance / Quality Assurance / Production of a pharmaceutical manufacturing facility
What the Team is Saying
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Diagnostics Launch Lead
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R&D Privacy Steward
Esteban
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Pfizer Compensation & Benefits Highlights
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Parental & Family Support — U.S. materials describe up to 26 weeks of parental leave (including up to 12 paid non‑medical weeks), with phased return‑to‑work plus fertility, adoption, and surrogacy financial support, backup care, lactation support, and caregiver leave. These offerings indicate depth in family‑building benefits and day‑to‑day caregiver resources.
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Healthcare Strength — Core programs commonly include medical, prescription drug, dental, vision, mental‑health/EAP resources, disability insurance, preventive health programs, and free or reduced‑cost vaccinations. Voluntary Benefit Extras and wellness resources broaden coverage and access.
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Retirement Support — Career pages and postings note a 401(k) with company matching plus an additional company retirement savings contribution in some plans. Company materials also reference financial‑planning education and colleague‑directed retirement funds.
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The Company
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.
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Pfizer Offices
Hybrid Workspace
Employees engage in a combination of remote and on-site work.
Typical time on-site:
Not Specified
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