Vacant job

Job Description

Do you want to play a key role in ensuring the highest quality and audit-readiness for one of our leading clients in the Life Science sector? Do you have extensive experience with quality systems, validation, and GMP documentation? Then this might be the right challenge for you!

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. This position is suitable for you who thrive in a responsible role with ample scope for independent initiative, and who wish to further develop within the Life Science sector.

About the Role

In this versatile and responsible QA role, you will work broadly to strengthen the site's core quality system and ensure that operations are constantly ready for regulatory inspections (QAFDA Audit Readiness). You will hold a senior profile where you act as a specialist and driving force in several critical QA areas – from administering GMP documentation and logbooks in eDMS, to handling complex IT quality issues. A central part of your role involves managing and approving risk assessments for data integrity (Data Integrity) as well as validation and qualification of computerized systems and laboratory equipment. Furthermore, you take responsibility for the site's systems regarding Change Control, deviations, and CAPA, which includes training, reporting, and continuous improvement work to enhance regulatory compliance.

Responsibilities

• Audit Readiness & Quality Systems: Drive and ensure constant QAFDA Audit Readiness, as well as be responsible for and strengthen the site's systems for change control, deviations, and CAPA.
• QA-IT & Data Integrity: Review and QA-approve risk assessments for data integrity, as well as validation and qualification of computerized systems and laboratory equipment.
• Documentation Management: Administer QA documentation, archive and review logbooks, and ensure correct GMP document handling in the eDMS system.
• Training & Compliance: Train the organization on quality systems, report key figures, and actively work to improve the site's overall compliance level.

Qualifications

• Experience: Several years of experience working in QA in a senior profile within Life Science (pharmaceuticals/medical technology) under strict GMP regulations.
• Technical Competence: In-depth understanding of computerized system validation, Data Integrity, and handling of laboratory equipment.
• System Knowledge: Substantial experience working in electronic document management systems (eDMS) as well as processes related to Change Control and CAPA.
• Language Requirements: Fluent in both Swedish and English, both verbally and in writing.

We place great emphasis 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 excellent collaboration skills and naturally take responsibility for ensuring that the group delivers 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 look for someone who is curious, goal-oriented, and proactive, and who contributes to a positive and supportive team climate through their engagement.

About the Company

Randstad

At Randstad, we know that every person has a place in the labor market. With operations across the country and within all competence areas, we help people find a job that feels right, 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 premier 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.