Quality Assurance Specialist - QMS

at  Hansa Biopharma

WOULD YOU LIKE TO BE PART OF A GROWING BIOPHARMA COMPANY?

Hansa Biopharma is a commercial-stage biopharmaceutical company, pioneering the development and commercialization of innovative, lifesaving and life altering treatments for patients with rare immunological conditions.
Our broad therapeutic pipeline based on the company’s proprietary IgG-cleaving enzyme technology platform has potential to address serious unmet medical needs in autoimmune diseases, gene therapy, and transplantation.
By empowering our people and working in an agile way we move our projects forward with high speed, efficiency and scientific excellence. We strive to attract leading talent from around the world, broaden our network of partners and establish a presence in key markets around the world. There are many opportunities for highly qualified, motivated, and passionate team players to join us on our exciting journey.
Hansa Biopharma was founded in 2007, with the corporate headquarters in Lund, Sweden and has operations in other European countries and in the US. The Company has been listed on the Nasdaq First North Growth Market Stockholm from 2007 to 2015 and on the Nasdaq Stockholm since 2015.

POSITION: QUALITY ASSURANCE SPECIALIST – QMS

At Hansa Biopharma we are a small QA team seeking a new colleague who thrives in a self-sufficient role and who is passionate about collaboration. If you are interested in actively contributing to supporting the quality mindset and continuing building and maintaining a compliant quality environment, you may be the person we are looking for.

PROFESSIONAL QUALIFICATIONS

In order to succeed in this position, you have relevant experience for the above responsibilities to be able to work both independently and collaboratively. We believe that you should possess:

• Life science education, e.g., nurse, pharmacist, lab technician or similar

• Experience in the Pharmaceutical/ Biotech industry, or the health sectorGood verbal and writing skills, in English

The following experience is desirable:

• Previous experience in a similar role
• Knowledge about Quality Assurance
• At least 3 years of experience in Life Science Industry, knowledge of GxP

PRINCIPAL RESPONSIBILITIES

• Assist with regulatory authority inspections/ internal or external audits by providing administration support
• Assist in preparing, conduct liaison meetings, drop-in sessions supporting Hansa staff
• Manage QA intranet page and QA general email inbox
• Responsible (system admin, superuser) for Hansa QMS (QMapp and Veeva), involved in on/off-boarding
• Prepare systems periodic review reports, manage change controls and support in issue handling
• Plan and prepare for Quality Management System (QMS) quarterly workshops by tracking quality parameters, overseeing and facilitating the development of QA Quality documents and providing overall support for Hansa Quality Document development
• Prepare the Quality Management Review report/presentation
• Responsible for the Physical Archive
• Assist Line and Quality Managers with the planning and organizing GxP Training, ensure the training matrix is updated, create training material as relevant

In order to succeed in this position, you have relevant experience for the above responsibilities to be able to work both independently and collaboratively. We believe that you should possess:

• Life science education, e.g., nurse, pharmacist, lab technician or similar
• Experience in the Pharmaceutical/ Biotech industry, or the health sectorGood verbal and writing skills, in Englis

As colleagues, we genuinely care about each other. We are friends, empowering one another and appreciating everyone’s unique traits and contributions, and we believe in working together as a team. To foster the best possible organisational match in this role, we hope that you recognise yourself as having the following characteristics:

• Service minded and self-motivated team player with a “can do attitude”
• Systematic approach with the ability to structure work duties and processes that involve others
• Strong communication skills with the ability to explain things in a pedagogical way and help seek solutions
• Social skills with the ability to collaborate with individuals of varying levels of authority and with different perspective