Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.
Post : Associate Quality Assurance
Job Description
• 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. Specialist or Supervisor.
• 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 Supervisor.
• Perform Equipment breakdown assessments w.r.t to Product Quality and patient safety with technical support/inputs from Sr. Specialist or Supervisor.
• Review and assessment of equipment alarms and review of quarterly alarm trends.
• Report any non-compliance to the Supervisor
• 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.
Candidate Profile
• Bachelor's Degree
• Experience in pharmaceutical industry
• Sound knowledge of current Good Manufacturing Practices {part of GxP}
• Ability to work in a team environment within own team and interdepartmental teams
• Effective written and oral communication skills
• Experience at a manufacturing site
• Experience of writing and managing deviations
• Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management
Additional Information
Qualification : B.Pharm
Location : Vizag
Industry Type : Pharma / Healthcare / Clinical research
End Date : 25th May, 2022
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