QA Officer

QA Officer

We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We're looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.

Learn more about how Baxter is At the Intersection of Saving and Sustaining Lives.

Baxter Lund are currently looking to recruit a QA Officer within the DVM compounding team where aseptically compounded products are manufactured in a clean room environment. Working closely with production to ensure all products are of high quality before being released, you will ensure compliance is continuously being followed and that Baxter products are released to the highest of standards.

DVM is expanding so we are looking for candidates who enjoy change, improvements and finding new ways to work and the challenges this can bring. You will need to be able to see the bigger picture and have a flexible mindset as a result.

Essential Duties and Responsibilities
  • You will review batch release documentation, environmental control data, perform specified QC batch inspection and support batch release activities.
  • Investigate deviations in compliance with GMP requirements and corporate procedures and define, raise and implement suitable CAPAs.
  • Support the implementation of Change Controls, completion of risk assessment and handle customer complaints.
  • Ensure all documentation is relevant and applicable to the process and is periodically reviewed and updated.
  • Report relevant quality KPI to the DVM Quality Lead.
  • Ensure all manufacturing operations comply with current GMP guidance.
  • Act as QA representative in audit processes relevant to DVM department.
  • Maintains regular contact and communication with the DVM QP on the performance and compliance of the Quality System/cGMP operations.
  • Contribute new ideas and challenge ways of thinking to support more efficient processes, product release and compliance so you can make things easier for production.
  • Degree level or equivalent in Pharmacy, Pharmaceutical science, Biotechnology, Chemistry, Microbiology, Engineering or equivalent
  • At least 2 years' experience of working in pharmaceutical manufacturing
  • At least 2 years' experience of quality system implementation and GMP
  • Collaborative mind set and good communicator
  • Fluent Swedish and English in both written and verbally is required
Ideally experience in the following areas;
  • Aseptic manufacturing of sterile products
  • Batch review / release
  • Root cause investigation and problem-solving techniques
  • Quality system management and implementation
  • Environmental / microbiological control
What we offer
  • A challenging opportunity for you and also a chance to work in a diverse and experienced team with a great mix of people. Joining Baxter means joining a team that you can truly learn from!
  • Independent position with an opportunity to build your own strategy and make a real impact
  • A chance to further build your professional experience in the area of health care
  • Internal training tailored to business needs and career goals
  • Stability of employment in a recognizable and established company
Mer info
Område Lund
Yrkesroll Organisation & ledning, Chefsbefattningar, Industri & Anläggning, Quality Assurance
Typ av anställning Heltid, Tillsvidareanställd
Sista ansökningsdag 30 nov 2020 (36 dagar kvar)