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MQA Upstream Specialist

4.00 to 6.00 Years   Vishakhapatnam   14 Sep, 2021
PFIZER LIMITED
Job LocationVishakhapatnam
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software,Quality (QA-QC)
EmploymentTypeFull-time

Job Description

ROLE RESPONSIBILITIES:

  • 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.
Preferred Education/ Qualification:B. Pharma / M. Pharma / M.Sc.Experience: 4-6 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 #LI-PFE,

Keyskills :
product qualityquality assuranceregulatory compliancemanufacturing qualitylegislative relationssopebrcgmpampspharmaalarmscontrolfillingassuranceems

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