QA Lead i Lund

Publicerad: 2017-05-15
Ort:
Lund, Skåne län
Kategori:
Life Science
Specialisering:
Läkemedel, bioteknik & medicinteknik
Omfattning:
Heltid
Referensnummer:
201053599
Sista ansökningsdag:
2017-06-06
Kontakt:
Camilla Wern
Telefonnummer:
0733-436098
Do you want to take part in Baxter´s new aseptic manufacturing in Lund? Are you an expert within Quality system implementation and an excellent communicator? Do you want to work for a global company where you every day have the chance to save and sustain people´s lives? If your answer is yes, you may be the candidate we are looking for!

Baxter will start up a new innovative extempore manufacturing in Lund where you will contribute to the set-up of the quality and manufacturing system. As Quality Assurance Lead you ensure compliance with the aseptic manufacturing license, regulatory requirements, cGMP and Baxter standards and policies. You lead the implementation, monitoring and maintenance of the Quality System where you are responsible for i.e. change control, complaints, CAPA, validation and audit . You work closely with the aseptic manufacturing to ensure the product meets specification and customer expectations on delivery and quality. You will be fully integrated in the Global Baxter QA organization for Compouding.

It is a challenging opportunity for you and also a chance to work in a diverse team with a great mix of people. Joining Baxter means joining a team that you can truly learn from! We encourage our employees to develop their skills to meet the demands of an ever-changing work environment, providing them with opportunities to achieve personal and professional goals that will make them valued contributors throughout their careers. If you have an interest in this great opportunity and think you can make a difference then this could well be the role for you. If you want to learn more about career opportunities go to http://www.baxter.com/careers.page

Qualification:
We are looking for a person with the following experience and qualification:

  • Education in pharmacy (at least 4 years study) or Chemical engineering (MSc)
  • Fulfill the requirements for a qualified person according to LVFS 2004:7
  • GMP knowledge both in theory and experience from the industry • Quality system implementation
  • Aseptic Manufacturing of Sterile Medicines or Compounding, microbiological control and validation
  • You have excellent English and Swedish in speech and writing.
  • If you have worked as a Qualified Person in compounding area (extempore) it is an advantage.
On a personal level, you have excellent communications skills. You are self-motivated and you have the ability to plan and execute activities with minimal supervision. You strive to deliver results. You like to work in a structured way with an eye for details. We place great emphasis on personal qualities for this role.

Company: Baxter

City: Lund

Job type: Full time

Deadline for applications: 2017.06.06

More information: This recruitment will be managed by Dfind Science & Engineering. For more information about this position please contact Recruitment Consultant Camilla Wern 0733-436098. The selection process is on-going so please apply as soon as possible, however not later than 2017.06.06. Please send in your application in English via https://www.dfind.se/science-engineering/

Organization/Business description:
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

Key words: QA, QP, GMP, Change Control, Compaints, CAPA, Valadation, Septhic, manufacturing, microbiological control, sterile compounds, extempore, quality, pharma