Group Senior Expert - QA IT
About the company
In this role, you will become part of Corporate Quality Assurance, a department of 16 people who bear the overall quality responsibility for the manufacturing of biological medicines. Manufacturing places extra high quality requirements and covers the entire chain – from raw materials to the finished product delivered to patients. You will work with quality assurance and compliance for the company's computerized systems, as well as ensure quality oversight through the review and approval of GMP documentation, with a strong focus on patient safety and product quality in both daily operations and projects. Furthermore, you will maintain and further develop the quality management system linked to IT systems and ensure that processes and regulations are complied with. The work is carried out in close collaboration with functions such as IT, production, engineering, quality control (QC), and Supply Chain.
Your tasks
Responsibilities Act as the QA representative in group-wide IT projects and manage ongoing oversight of IT systems during releases, updates, corrections, improvements, and reviews. Review and approve qualifications and validations related to equipment and IT systems at the group level. Serve as a Subject Matter Expert (SME) within QA and support qualification and validation activities for both IT systems and equipment. Review and approve internal routines and procedures linked to IT, IT applications, and qualification/validation. Ensure compliance with quality requirements in IT-related processes and during the systems' lifecycle management. Responsible for the qualification of external suppliers of IT systems and services, including conducting supplier audits.
Requirements
Job Description Are you an experienced quality expert within IT and computerized systems who wants to work in an operationally close and socially important role? We are now looking for a Group Senior Expert – QA IT for an exciting assignment with a leading player in the pharmaceutical industry.
University degree in, for example, chemistry, chemical engineering, pharmacy, or an equivalent relevant field. At least 5 years of experience in quality work within the pharmaceutical industry. In-depth knowledge of current GMP regulations as well as 21 CFR Part 11 and EU Annex 11. Documented training in validation of computerized systems (CSV) within the pharmaceutical industry. Solid understanding of quality management standards relevant to qualification and validation. Very good knowledge of English, both spoken and written (Swedish is a merit / fluency is a strong asset).
Other
The position is full-time with an immediate start by agreement, and the work is performed 100% on-site at the office/facility in Hornsberg on Kungsholmen. The assignment is a consulting assignment with a hire-purchase solution, where the ambition and plan is for the client to over-recruit you to a permanent position after 6–12 months.
About the company Randstad At Randstad, we know that everyone has a place in the labor market. With operations across the entire country and within all competence areas, we help people find a job that feels good, and where they get the opportunity to grow, develop, and achieve their full potential. With nearly 600,000 employees in 38 countries, Randstad is a world leader in HR services, with the goal of becoming the world's leading and most appreciated partner in the labor market. By combining our passion for people with the power of today's technology, we help people and companies achieve their full potential. We call it Human Forward.