Pfizer
MQADownstreamAssociateManager
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“MQA Downstream Associate Manager at Pfizer. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement. MES quality operations. Maintain regulatory compliance”
What You'll Achieve.
delivery of safe and effective products; patient first; operating state of cGMP compliance
Industry & Context.
assessing the impact of AMPs exceptions; Equipment breakdown assessments
Work Location Assignment: On Premise
What They're Looking For.
Must Have
6-8 years of experience in Manufacturing Quality Assurance / Quality Assurance / Production of a pharmaceutical manufacturing facility, Shall able to work in the shifts
What You'll Do.
MES quality operations
Maintain regulatory compliance
Ensure manufacturing policies conform
assessing the impact of AMPs exceptions
Review of Batch reports
Equipment audit trails
Perform Acceptable Quality level sampling
Inspection and record the results
Perform batch start-up and end activities
Perform random process checks
Perform Daily walkthroughs
Perform Equipment breakdown assessments
Review and assessment of equipment alarms
review of quarterly alarm trends
How You'll Work.
Team & Collaboration
technical support/inputs from Sr. Team leader
Full Job Description
**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. Wo
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