Senior TPM
Abbott
İstanbul, İstanbul TR
son 15 saat
source : ISPE

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 activitiesManagement 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’sParticipating 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 proceduresResponsible for maintaining TPM / Supplier Quality Technical Agreement","industry" : "Healthcare","title" : "Senior TPM-Suppliers QA AssociateDivision : EPD Established Pharma

    Travel : Yes, 25 % of the Time

    Medical Surveillance : No

    Significant Work Activities : Not Applicable

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