Vacant job

Job Description

Do you want to contribute to strengthening the quality systems of a leading player in the pharmaceutical industry? We are currently looking for several driven and meticulous employees in Quality Assurance (QA) for our client's facility in Uppsala. Here you will have the opportunity to work with everything from documentation management to IT system validation and strategic compliance work, in a role that ensures the business is ready for regulatory audits (FDA / Audit Readiness).

About the Role and Operations

In this dynamic role, you will become a key person in the client's quality team, where the overall focus is on maintaining the highest possible standard ahead of upcoming FDA inspections and external audits. Depending on your specific background and experience profile, the emphasis of your assignment will lie within one or more of our focus areas: documentation administration, IT Quality Assurance (QA-IT), and strategic work with the site's central quality system. You will work in a modern GMP environment where data integrity and regulatory compliance permeate all work.

As a consultant at Randstad, you will become part of a strong and cohesive team at our client's site, while having Randstad's security and support behind you. The position suits you if you thrive in a responsible role with great scope for independent drive, and who wish to develop further within the Life Science sector.

We are recruiting during the summer, but due to holidays, the process and our feedback may take slightly longer than usual. We handle applications on an ongoing basis and appreciate your patience during the vacation period.

We look forward to receiving your application!

Responsibilities

• QA Documentation & Administration: Responsible for reviewing and archiving logbooks as well as administration of documentation systems in eDMS according to current GMP regulations.
• QA-IT & Data Integrity: Perform validation and quality assurance of computerized systems and laboratory equipment.
• Review & Approval: Evaluate and approve risk assessments regarding data integrity (Data Integrity Risk Assessments) as well as qualifications of IT and lab systems.
• Quality System & Compliance (Senior profile): Strengthen and develop the site's central quality system with a focus on continuous improvements and increased compliance levels.
• Case Management: Responsible for and driving processes related to change control, deviations, and CAPA systems.
• Training & Reporting: Conduct internal training within the quality system as well as compile and present compliance reporting to management.

Qualifications

• Relevant academic education in natural sciences, pharmacy, engineering, or a corresponding field.
• Experience with QA work in the pharmaceutical industry or another strictly regulated GMP environment.
• Good understanding of documentation management in eDMS as well as handling and archiving of logbooks according to GMP.
• Experience with validation and qualification of computerized systems (CSV) as well as application of data integrity principles (Data Integrity).
• Experience in independently driving and investigating Change Control, deviations, and CAPA cases (especially advantageous for the senior profile).
• Good laboratory knowledge to the extent required to understand and quality assure the underlying processes at the facility.
• Language requirements: Fluent in both Swedish and English, both spoken and written.

Personal Qualities

We place great importance on your personal suitability for this position. To thrive and succeed in the role, you are a methodical, structured, and meticulous person who always puts quality first. You have very good collaboration skills and naturally take responsibility for the group delivering together according to set timelines and strict quality requirements. Since the environment can change, you are flexible and communicative, with the ability to independently drive your work forward. We also see that you are curious, goal-oriented, and proactive, and that with your engagement you contribute to a positive and supportive work climate in the team.

About the Company

Randstad

At Randstad, we know that every person has a place on the labor market. With operations throughout the country and within all competence areas, we help people find a job that feels good, where they have the opportunity to grow, develop, and reach their full potential.

With nearly 600,000 employees in 38 countries, Randstad is the 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.