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Hiring for IPQA

2.00 to 4.00 Years   Kolkata   26 May, 2020
Sygene
Job LocationKolkata
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

Primary Responsibilities:

  • Supervise the Environmental Monitoring activities for compliance and aseptic practices within biologics facilities.
  • Presence during area qualification activities.
  • Issuance of logbooks and review of executed logbooks for completeness.
  • Line clearance for batch to batch and product to product changeover.
  • Perform the line clearance activities for the material dispensing in Warehouse.
  • Routine facility rounds to ensure compliance in manufacturing and warehouse.
  • Ensuring that good aseptic practices are followed inside the facility.
  • Execute GMP support activities (under the purview of QA) under observation of supervisors.
  • Physical verification of CAPAs in the facility triggered from audits/Quality Management System.
  • Inspection of Raw material (RM), packing material (PM) and manufacturing consumables for any damage/discrepancy possible during receipt, storage, dispensing and handling of these materials in Warehouse.
  • Verification of the SAP related activities used by Warehouse, QC, and Manufacturing related to receipt, sampling, testing, shelf life assignment, releasing, dispensing, storage, retesting, control sample testing, reconciliation and disposal of RM/PM and consumables.
  • Cell bank receipt, storage, usage, disposal and reconciliation logs as per client requirements and internal procedures.
  • Approval of vendors by desktop and site audits (as required).
Physical verification for closure of Work Orders.,

Keyskills :
sampling testing disposal packing storage materials vendors control packingmaterial shelflife arehouse

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