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specialist - Batch Record Preaparation

3.00 to 5.00 Years   Vishakhapatnam   14 Sep, 2021
PFIZER LIMITED
Job LocationVishakhapatnam
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD,Pharmacist / Medical Representative
EmploymentTypeFull-time

Job Description

  • Bachelors Degree
  • Demonstrated working knowledge and understanding of manufacturing process
  • Experience in Preparation of Batch records
  • Ensure compliance to GDP and ALCOA Principles during document preparation.
  • Initiation and closure of the Change controls related to batch record preparation and revision
  • Tracking and implementation of production CAPAs.
  • Responsible for the CCF initiation, coordination with CFT for impact assessment and CCF pre-approval, responsible for closure of CCF.
  • Well versed with Microsoft word, excel and power point presentation.
  • Good Knowledge on regulatory guidelines.
  • Knowledge on ALCOA principles.
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 :
equal employment opportunitycontinuous improvement facilitationmicrosoft wordquality assuranceimpact assessmentlegislative relationsccfwordexcelclosurecontrol

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