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    Quality Specialist - København, Danmark - Ortolan

    Ortolan
    Ortolan København, Danmark

    for 1 uge siden

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    Quality Specialist

    Copenhagen, Denmark (hybrid: 3 days office, 2 days home)

    Salary: Competitive + Benefits + Bonus

    If you are an agile, committed, and innovative pharmaceutical quality specialist, then we want to hear from you

    Join us to help improve peoples' lives and make healthcare better for everyone

    Why Pharmanovia?

    Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.

    Our core behaviours are:

  • We act decisively but we never compromise on quality.
  • We keep our promises and do as we say.
  • We value our heritage and foster an entrepreneurial spirit.
  • We reinvest in our future - in our products, our brands, and our people.
  • We give back to our communities. Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, U.A.E., India, Singapore, Italy, Spain, and South Korea. We are an agile, committed, and innovative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce. Pharmanovia's therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology. About the role: As Quality Specialist, you will take on the role of quality assurance partner for all activities related to finished goods manufacturing activities, daily operations, optimisation projects, and partner collaboration. Our Quality Department has an ethos of continuous improvement, refining systems and creating efficiencies. This, along with the rapid growth of the business, leads to a varied and dynamic working environment. Reporting to the Associate Director EU Batch Release (QP/RP), this position is based in Copenhagen, Denmark. Main responsibilities & duties: Quality Assurance:
  • Maintenance of the Quality Manual
  • Maintain the QMS according to applicable legislation (GMP, GDP and GVP)
  • Batch Review
  • Ensure samples are decommissioned as appropriate
  • Ensure amount of release packs are uploaded correctly into the EU-HUB before QP release
  • Preparation of CoC + CoA
  • Prepare inspection plans for ERP system SAP /4 HANA (Release)
  • Deviation handling
  • Handling of Change Control
  • Review incoming customer complaints and prepare responses to internal/external customers
  • Trend analyses for complaint and deviation
  • Performing supplier evaluation for API manufacturers, finish product manufacture, warehouses, wholesalers, distributer, and others
  • Preparation for self-inspection
  • Prepare audits for GDP suppliers
  • Facilitator of weekly QA board meetings Pharmacovigilance :
  • Handling PV information/ADR to PV-consultant About you: Candidates with several years' experience of GMP release processes within the pharmaceutical industry are likely to have the skills required to be successful in this role. We are also looking for:
  • Bachelor's degree in pharmacy, science, or a related field
  • Great IT skills including MS Office
  • SAP experience
  • Experience in GDP management
  • Strong organisational skills to establish priorities including scheduling and meeting deadlines
  • Experience in project coordination
  • Analytical, detail-oriented
  • Excellent time management skills with demonstrated ability to juggle multiple competing tasks and demands
  • Ability to work successfully within cross-functional international teams
  • Proactive with a positive and flexible mindset
  • Ability to think out of the box, willing to learn and adapt to new processes
  • Passion for quality and compliance
  • Excellent professional communication skills
  • Excellent Danish and English language skills (written and verbal) What we offer: We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working.

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