Job Description
Vacancy for Associate Quality Assurance at Pfizer.
Job Title/Position:
Associate Quality Assurance
Job Overview:
Job vacancy for Pharmacy
Job Location:
Vizag
What are the Key Responsibilities?
• 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.
What are the Educational Qualification(s) for this position(s)?
B.Pharm
What is the Experience Required for this Job?
Experience in pharmaceutical industry
What are the Preferred Skills required for this Job/Position?
• 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
Related:
Vacancy for Associate-Pharmacovigilance at Accenture
