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Associate Director - Qualification & Validation (Sterile)

15.00 to 22.00 Years   Indore   19 Jun, 2021
Job LocationIndore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

Roles and Responsibilities

  • Will be a as Lead Validation
  • Responsible for optimization of Validation activities with cost effective solutions
  • Prepare, Execute, Review & Approve Validation Master Plan, Validation plan, Project validation plan, commissioning / Qualification / Validation of Equipment s/system/process documents (like URS, DQ, FAT, SAT, QRM, IQ, OQ, IOQ,PQ, IQ, PRQ) used in a Sterile Facility
  • Will be responsible for Site periodic calendar based validation activities to support commercial manufacturing.
  • Responsible for all aseptic medial fills.,PFS, Isolators, Cartridge, Lyo, validation activities
  • Responsible to track the QMS activities.
  • Experience in Regulatory audit facing like USFDA
Desired Candidate ProfileThe incumbent will be head of the validation and qualification activities. Strong exposure to sterile operations is required.,

Keyskills :
financeadvisorycompliancereportingcustomer relationscost effectiveoptimization strategiesqmsurssatqrmequipmentisolatorsoperationscommercialregulatoryvalidationcommissioning

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