Pfizer Hiring for MQA Upstream Specialist at Visakhapatnam Full Time

• 0-2 years’ experience in Manufacturing Quality Assurance / Quality Assurance/ Production of a pharmaceuticals manufacturing facility.
• B. Pharma / M. Pharma / M.Sc.
• Responsible for ensuring operating state of cGMP compliance in solution/emulsion preparation, vial/ampoule washing, depyrogenation, filling and capping 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 EMS alarm impact assessments and monthly trend reports.
• Ensure start-up and in-process activities performed as per batch record and SOP compliance.
• Monitor the manufacturing practices and ensure compliance with respect to standards and approved procedures.
• Perform daily walk throughs and report observations to the supervisors.
• Perform equipment breakdown assessments w.r.t to product quality and patient safety with technical support/inputs from Sr. Specialist or Supervisor.
• Review and approval of equipment alarms and review of 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.

Quality Assurance and Control

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