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QUALIFICATIONS AND JOB DESCRIPTION

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.


As Abbott Turkey, we help people live healthier and better lifes through our Established Pharmaceuticals, Diagnostics, Nutrition, and Medical Devices business for more than years. We have approximately 750 employees working nationwide in different areas.

Abbott Established Pharmaceuticals Division is looking for a Senior TPM-Suppliers QA Associate

Your Qualification:

  • 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 followup 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 ofdeviation/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



PREFERRED CANDIDATE

POSITION INFORMATION

Firma Sektörü:

İlaç Sanayi

Çalışan Sayısı:

750-999