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Sr. Associate Compliance

5.00 to 10.00 Years   Delhi   17 Nov, 2021
PFIZER LIMITED
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaCustomer Service (Domestic),Sales / BD
EmploymentTypeFull-time

Job Description

QualificationsGraduate in Science/Pharmaceutical Science DisciplineExperience5 Years of experience in documentation

  • Ensure compliance to GDP and ALCOA Principles during document preparation.
  • To prepare the Quality Risk assessment for the equipment and process, tracking for the implementation of QRM mitigation plan
  • Responsible for the Preparation of Master manufacturing records and Master Packing records for the commercial batches.
  • Responsible for the CCF initiation, coordination with CFT for impact assessment and CCF pre-approval, responsible for closure of CCF.
  • Procedural updation as per approved CCF and ensuring PLS upload.
  • Monitoring of action items addressed in the CCF and closure as per the timelines mentioned in CCF
  • Responsible for review of commercial, scale up, exhibit, intended and Process validation master manufacturing records and packing records.
  • Preparation of response for audit observations, propose CAPA taking consent of SME, owner, and QA for identified action items.
  • Track the activity related to response and send update to owner
  • Interact with investigator for CAPA plan and support in investigation
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 opportunityenvironmental impact assessmentcontinuous improvement facilitationrisk assessmentquality assuranceimpact assessment

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