QA Investigational Medicinal Products (IMP)

QA Investigational Medicinal Products (IMP)



Role & Function

Sobi is looking for a senior Quality Assurance professional for the Investigational Medicinal Products (IMP) operations. This role means working with a wide range of tasks and in close collaboration with Sobi’s external parties throughout the whole drug development and manufacturing process, in order ensure GCP compliance and product quality. As a QA IMP you will be part of the global Sobi Quality Assurance team reporting to Sobi HQ, Stockholm.

The QA team is currently responsible for the Quality Assurance and release of Drug Substance, Drug Product and Finished Goods. The responsibility of the team is now broadening to cover also quality oversight of clinical activities of both new as well as established products. The medicinal products are biological, sterile and non-sterile (small molecular) and are manufactured in the dosage forms of lyophilized powder, injectable solutions and tablets. In this position you will become part of a highly competent team were collaboration and teamwork is highly valued.

The position is a permanent employment with placement in Stockholm, Sweden.
Key Responsibilities




• Act as an expert/advisor for the organization and product teams in clinical related topics
• Review of batches and preparation for release
• Issuing of product specifications and study specific documentation as well as quality documentation
• Establishment of quality agreements
• Being QA for deviations, change errands and CAPAs
• Participate and support both external and internal audits including also authority inspections
• Develop quality assurance standards and company processes
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Personal attributes

Are you interested in working at a company in a growing phase and that makes important difference to patients’ lives?
In order to succeed in this role, you should have practical experience of working as QA for investigational medicinal products in clinical studies, you are driven, with good planning skills, and be able to independently take initiatives and make decisions.

You are a natural QA leader that thrives in a role where communication and collaboration is key, and you can create and maintain rewarding professional relationships both internally and externally. Furthermore, you can also quickly manage new situations/issues and handle several topics at the same time. The right candidate shares the Sobi values: Care, Ambition, Urgency, Ownership, Partnership
Qualifications




• Pharmacist Degree or other higher education on master’s level
• At least 5 years’ experience in the healthcare/pharmaceutical industry, gained preferably from Quality Assurance roles working with clinical studies or activities
• Strong GMP and GCP knowledge and experience
• Previous experience of biological/sterile products is meritorious.
• Excellent English langue skills (both written and verbal communication.)
• Swedish langue skills are meritorious.
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Location

The position will be based in Stockholm, Sweden.

Reporting to

Director QA Haematology SE

Next step in the process

In this recruitment drive, Sobi is collaborating with Mpya Sci & Tech. Please, submit your application as soon as possible as we will be calling for interviews on an on-going basis. If you have any questions regarding the recruitment process or about this role, you are welcome to contact Josefine Wejerstrand, josefine.wejerstrand@mpyascitech.com, 073-144 84 46.

Welcome with your application no later than 25th of March.