Senior TPM-Suppliers QA Associate
Abbott
Istanbul, Turkey
son 1 gün

QUALIFICATIONS

  • Bachelor’s Degree in Pharmacy, Chemistry or Chemical Engineering and minimum 7 years of QA / QC, production experience in the pharmaceutical industry
  • Expertise in cGxP, ICH and other national and international regulations. Knowledge of domestic and international regulations related with Incoming Pharmaceutical Material / Pharmaceutical drug product manufacturing
  • Expertise in validation qualification activities preferably Process Validation, Cleaning Validation, Equipment Qualification.
  • Strong analytical mind, problem solving, negotiation, delivery result and follow up skills combined with networking capabilities
  • Communication ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner with internal and external stakeholders.
  • Fluent in written and spoken English
  • Ability and flexibility to travel (Domestic and Out of Country)
  • JOB DESCRIPTION

  • Accountable for the product quality performance at TPM (Third Party Manufacturer), to ensure compliance according to the related regulations and Abbott Global / Regional Policies.
  • Responsible for product quality performance through product and supplier Quality Risk Management of deviation / investigation, change management processes, Product Quality Reviews, CAPAs, Stability program and other quality related tools.
  • Maintain good relation and communication with TPM, suppliers and internal stakeholder during management of all quality activities
  • Management and communicate quality complaints with TPM / Suppliers to get proper investigation report.
  • Communicate quality and compliance expectations with TPMs / Suppliers and follow performance to assure compliance with cGMP and Abbott Global / Regional Policies and support for improvement quality system.
  • Reviewing and approving TPM quality documents like Batch Manufacturing records, packaging records, validation plans, validation reports, stability plans, and stability reports, PQRs, etc.
  • Reviewing and approving change controls, exceptions, deviations and CAPA’s
  • Participating on site quality activities to support TPM / Supplier for improving / solving the quality problems regarding product or site quality system.
  • Responsible for maintaining proper documentation system as per Global / Regional Abbott procedures
  • Responsible for maintaining TPM / Supplier Quality Technical Agreement
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