IT QA Specialist

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Are you an experienced professional in pharmaceutical compliance with a passion for IT/OT?
If so, this could be the perfect job for you! We are currently seeking an IT QA Specialist who will help us set the direction for Quality Management of digital and IT solutions and services in a regulated environment at [xxxxx] Pharmatech A/S in Køge.The Position
In the role of IT QA Specialist, you will be responsible for establishing the direction for our IT quality system and ensuring compliance with requirements from both customers and regulatory authorities worldwide.Your tasks will include:
  • Serve as a QA partner with expertise in IT compliance and GMP, collaborating with stakeholders and providing subject matter expertise for projects.
  • Approve deviations, change requests, qualifications, and validation documentation to ensure regulatory adherence.
  • Assist stakeholders in effectively implementing complex changes and defining quality requirements.
  • Lead initiatives to optimize processes while maintaining high compliance and quality standards.
  • Share knowledge and promote good IT practices through training and hands-on activities for colleagues in a regulated environment.
    • In addition to these responsibilities, you will ensure that our quality assurance standards are met across all projects. This will involve regular engagement with multiple stakeholders to maintain compliance with industry standards.As a QA Specialist, your expertise will be crucial in mentoring other IT QA team members, fostering a culture of quality, and promoting a proactive approach to quality assurance. Your experience will help ensure that all processes adhere to the highest standards of quality and compliance, contributing to the overall success of our IT initiatives.You may also take on the role of IT Compliance responsible in various projects, covering the implementation of new equipment, upgrades of current IT systems, and optimization of business processes using new technologies.Looking ahead, we will optimize and streamline our IT Quality Management System (QMS) to support new digital solutions. This is an exciting and challenging role within a dynamic department where collaboration and team spirit are prioritized. We offer significant flexibility and warmly welcome diversity and new ideas.Qualifications
    To succeed in this role, you have:
  • An academic degree in Engineering, Computer Science, Biotechnology, business administraion, automation & controls or equivalent experience/education.
  • A minimum 6+ years of extensive experience with Quality Assurance within the pharmaceutical or similar industry.
  • Demonstrated experience with GMP (Good Manufacturing Practice).
  • A keen interest in IT, with experience in software validation (GAMP5) seen as an advantage.
  • Professional proficiency in English.
    • As a candidate, you will possess excellent interpersonal skills and an innovative mindset. You are capable of working effectively in a team-oriented environment and enjoy engaging in technical discussions with a wide range of stakeholders. Your personality should reflect openness, honesty, and a focus on continuous improvement and a quality mindset. A can-do attitude, coupled with an emphasis on exploring opportunities rather than limitations, is essential.About the Department
    [xxxxx] Pharmatech A/S is a fully owned subsidiary of [xxxxx] A/S located in Køge. We are a leading global supplier of high-quality ingredients for the biopharmaceutical and pharmaceutical industries, including products like recombinant insulin for cell growth media and pharmaceutical-grade quaternary ammonium compounds.
    The QA Operations team is part of the QA/RA department at [xxxxx] Pharmatech A/S, comprising 20 employees dedicated to supporting the entire value chain, from Research & Development to Production and finally Sales & Marketing. We also manage quality and regulatory communications with authorities, B2B customers, distributors, and suppliers.Working at [xxxxx] Pharmatech
    With approximately 500 employees, [xxxxx] Pharmatech A/S is entirely owned by [xxxxx] A/S. Our capability to produce and deliver quality products to the pharmaceutical industry, along with our comprehensive range of services within regulatory requirements, makes us a preferred supplier for many global pharmaceutical companies. As a growing company, we offer numerous exciting projects and development opportunities in the position.Contact
    For further information, please reach out to QA Manager, Sara Hoff, at +[xxxxx].Deadline
    10 August 2025. Interviews will not be conducted before week 35 due to the summer vacation.You do not need to attach a cover letter to your application, but please include a few sentences about your motivation in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.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.


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

    Arbejdsstedet er beliggende i Køge.

    Jobbet er oprettet på vores service den 27.6.2025, men kan have været deaktiveret og genaktiveret igen.

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