Temporary C&D QA Associate
Abbott
Istanbul, Turkey
son 6 gün

JOB DESCRIPTION : QUALIFICATIONS

QUALIFICATIONS

  • University degree preferably in Chemistry, Chemical Engineering or Pharmacy
  • Minimum 2-4 years of experience in quality control, quality assurance and warehouse operations at pharma industry
  • Thorough knowledge and experience of cGMP quality and compliance regulations, Good Warehouse Practices (cGWP) & Good Distribution Practices (cGDP)
  • Have an experience in product market release, batch documentation reviews, return goods & customer complaints management, 2D barcoding system applications
  • Experience in QA documentation practices & SOPs, training, change control systems, exceptions and CAPA management
  • Good knowledge of supplier evaluation and qualification process and audit management
  • Experience in artwork development and control is a valuable asset
  • Excellent command of English, verbal and written
  • Strong analytical thinking, problem solving and negotiation skills
  • Deliver results and excellent in follow-up
  • A good team player with strong communication capabilities
  • Proficient computer skills
  • Position will be located in Gebze&Ümraniye.

    JOB DESCRIPTION

  • Maintaining quality systems to ensure compliance to company policies, cGMP, cGWP and local regulations
  • Implementing quality assurance processes in affiliate and 3PL (Third Party Logistics) warehouse.
  • Reviewing and approving batch documentation for incoming products & secondary packaging processes and product release to market, return goods management
  • Complaint management and documentation
  • Managing related documentation systems in the affiliate and warehouse, updating related procedures
  • Reviewing and approving change controls, exceptions, deviations and CAPA’s, taking related actions to prevent the occurrence of any non-conformances relating to product, process and quality systems.
  • Managing supplier qualification system for affiliate; preparing annual supplier audit schedule, monitoring and auditing suppliers, performance monitoring for suppliers
  • Preparing annual training and audit schedules for affiliate, performing internal audits, and monthly training system follow-up
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