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Quality Assurance Operations Expert

  • Gdańsk, pomorskie
  • Specjalista
  • 12.04.2017

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    Quality Assurance Operations Expert/
    Qualified Person
    Place of work: Gdańsk

    JOB DESCRIPTION:

    • ensuring cGMP and regulatory compliance of operations leading to biological Drug Substance and Drug Product
    • supporting life cycle management of a manufacturing facility up to and including GMP compliant market production
    • in charge for the release of commercial products
    • ensuring that all processes and products in the unit have built-quality and meet all internal and external requirements through qualification and validation based upon quality risk analysis, product quality assessments and ongoing verification
    • conducting activities related to the establishment, implementation and supervision on the required quality processes in product development, manufacturing, testing, storage and distribution
    • taking decision on the use of batches of finished products – Certification according to Annex 16
    • preparation of CoA and CoC
    • batch record review and review of all batch related documents
    • participation in investigation on deviations and complaints, OOS/OOT, recalls and escalations, supporting change control requests, assuring GMP and regulatory compliance in the requests, participation in risk assessments
    • supporting all product/process related activities e.g. process transfers, process characterization, process validation and continuous process verification (including e.g. stability studies, hold time studies, E&L)
    • approval of protocols and reports, preparation of APQR
    • reviewing and preparation of quality agreements
    • preparation and reviewing of required GMP documents, assistance in the coordination and preparation of Polpharma Biologics for the inspections and controls, participation in internal and external audits
    • supporting the establishment of Quality Management System documentation
    • developing and updating the system with GMP documents, policies and standards for QA and QC in accordance with the requirements of Polpharma Group and the HA requirements of the areas where the products are marketed
    • ensuring the correctness and data integrity of all regulatory relevant development and manufacturing data

    REQUIREMENTS:

    • higher education in biology, chemistry, pharmacy, biotechnology or related, supported by minimum 5 years of work experience in the pharmaceutical industry
    • two years in the evaluation of pharmaceutical products in the area of ​​control or quality assurance
    • excellent knowledge of GMP requirements and pharmaceutical laws and regulations related to pharmaceuticals, especially in the ICH environment
    • Understanding of analytical technologies related to the evaluation of biopharmaceutical products, knowledge in technologies producing sterile pharmaceutical products
    • knowledge of Quality Management Systems
    • understanding the issues and needs of ualification and validation in biopharmaceutical manufacturing
    • knowledge in Quality Management Systems including quality requirements in clinical trials and Pharmacovigilance experienced in biotechnology manufacturing
    • fluent knowledge of English both, written and spoken

    WE OFFER:

    • employment contract  with opportunity to help shape the success of a leading private pharmaceutical company
    • working in a cutting edge biotech laboratory
    • great opportunity for professional development and participation in training programs
    • competitive salary, performance-related bonus and attractive fringe benefits