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The MQ TS Downstream Associate 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.
Job Responsibility:
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
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.
Requirements:
M. Pharma / Msc with more than 1 year experience in Manufacturing Quality Assurance / Quality Assurance / Production of a pharmaceutical manufacturing facility
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