Mq Upstream Associate
1 week ago
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.
- Qualification: B. Pharma / M. Pharma / M.Sc. ( 0-2 years’ experience in Manufacturing Quality Assurance / Quality Assurance/ Production of a pharmaceuticals manufacturing facility. )
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control
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