QA Specialist for QC and Analytical Development

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Gentofte

Do you have solid experience in Quality and have a proven track record in ensuring high-quality products that make a difference in the lives of patients with chronic diseases? Are you eager to take on new challenges and, together with experienced colleagues, shape the future of QC? Are you described as a positive, helpful, and enterprising colleague who takes pride in getting things done and keeping good stakeholder relations? Then you might be the perfect fit for the position as QA Specialist in our team in Biotech and Rare Disease (BRD) QA for QC! The position
As QA, our key task is to ensure products of the highest quality to serve our patients. We safeguard the processes surrounding the release of analytical results in full compliance with expectations from authorities. You will oversight of quality activities at our BRD QC laboratories in Gentofte, Hillerød and Kalundborg.
Your main responsibilities will include:
  • Review and approval of several types of GMP documents related to laboratory equipment, IT and analytical methods (HPLC, Bio- and Immunoassay and general pharmacopoeia methods incl. microbiology).
  • Setting direction for the laboratory process groups across [xxxxx].
  • Support the development and validation of analytical- and microbial methods, both in-house and at our Contract Manufacturing Organizations.
  • Improving QC processes through engagement in projects implementing new technology and equipment, and active participation in Inspections from Health Authorities.
  • We take pride in assuring that you always have challenging and impactful working assignments to ensure continuous development and realization of your full potential. Equally important, we have a high focus on a great work-life balance, with the flexibility to work from the office and home.
    Qualifications
    We are looking for an experienced colleague with a strong background in QA or QC.
    To succeed in this role, you:
  • Have Master’s degree in a relevant field and carry extensive experience in the pharmaceutical industry.
  • Know how to independently identify and drive complex working assignments.
  • Engage in critical cases, set direction for projects and entry of new products where you safeguard the product quality and patient perspective.
  • Have an interest and talent for implementing strategy across BRD.
  • Have proficiency in both English and Danish.
  • As a person, you have a curious, innovative, and solution-oriented approach to overcoming challenges. Your communication style is strong and respectful, excelling in both giving and receiving feedback. You foster positive relationships with stakeholders, ensuring collective success. You are bold and know how to balance quality demands, authority expectations, and business needs. You act as a role model for junior colleagues and know how to convey complex knowledge. About the department
    You will join a highly dynamic and well-functioning department in BRD QA with many interfaces and stakeholders around the organization. The department consists of three teams who are supporting and overseeing QC laboratories and analytical methods, support functions to production and product life cycle and are highly involved in the core of quality processes and authority inspections. The department have a high level of self-governance, and the working relations are informal. We value good humour and an open and honest culture. Working at [xxxxx]
    At [xxxxx], we don't wait for change. We drive it. We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We are anchored on scientific innovation through the power of our diverse differences. We embrace the spirit of experimentation and strive for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we are all working together to advance patient care.
    Contact
    For further information, please contact Manager BRD QA QC, Anne Dam Poulstrup at +[xxxxx].
    Deadline
    27 May 2024
    You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. Applications will be evaluated continuously when received, and candidates may be called for interview before the deadline.
    We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


    Information og data

    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Gentofte.

    Jobbet er oprettet på vores service den 14.2.2024, men kan have været deaktiveret og genaktiveret igen.

    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
    • 13.05.2024
    • Øvrige
    • Gentofte

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