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QC Stability Expert

  • Gdańsk, pomorskie pokaż mapę
  • Specjalista
  • 15.06.2018

    Pracodawca ma prawo zakończyć rekrutację we wcześniejszym terminie.

    if you want to work

    in one of the
    most modern biotechnology
    centres in Europe
     
    in place where
    profesionals
    from all over
    the world work
    on the highest-quality equipoment
     
    in the production
    of biotechnological
    drugs, which dive
    access to effective
    therapy to more
    patients
     
    in a company that will
    dive you stable
    employment competetive
    remuneration attracive
    benefits and the
    opportunity to participate
    in training at home
    and abroad
     
    Currently we’re looking for
    1
    QC Stability Expert
    Location: Gdańsk

    Join “start-up” Biologics division with strong international and local team at site!

     

     
    We are waiting just for you!


     
     

    What will you do?

    • Main responsible person for Documentation and Standards in QC Polpharma Biologis
    • Ensures that all data in the lab area are accurate and integer on paper and electric records
    • Ensures that all QC documents (plans, reports, results, method, specifications, etc.) are well managed,  consistent and compliant.
    • Reviews  CAPAs, deviations, change controls, OOSs, risk analysis and ensures all records  are closed in a timely manner and according to procedures.
    • Assists owners in CAPA, root cause analysis, deviation investigation, OOS investigations, risk analysis
    • Ensures that the most updated regulation (USP…) is implemented
    • Pull and analyzes metrics to measure effectiveness and makes recommendations
    • Interfaces auditors during inspections, participates to QC internal audit
    • Ensures that all corrective actions from internal and external audits are effective and verified
    • Follows, interprets and develops written Policies and Standard Operating Procedures
    • Monitors internal audit non-conformances, perform trend analyses, and present findings
    • Participates in process improvement activities to continuously improve effectiveness
    • Reviews completed quality records to ensure completeness and adequacy.
    • Participation or lead in documenting, investigating, troubleshooting and preventing recurrence of deviation
    • Represents Polpharma with clients and prospective clients
    • Participation  and representation of Polpharma Biologics in internal/external audits
     

    What do we expect?

    • Higher education in biologics, chemistry, pharmacy, biotechnology or related,  supported by min. 2 years of work experience in the pharmaceutical industry
    • Excellent knowledge of GMP requirements, pharmaceutical laws and regulations for pharmaceuticals, especially for biopharmaceutical drug substance and sterile products and stability studies
    • Knowledge of physicochemical, biological and microbiological methods
    • minimum 2 years of laboratory experience (in regulated environment)
    • Fluent knowledge of spoken and written English