Quality Assurance Specialist

Quality Assurance Specialist

TMC is growing within life sciences and med tech. Our Gothenburg office is entering an expansive phase, and we are now looking for more Quality Assurance Specialists to join our team!

As a Quality Assurance Specialist in our Life Sciences & Med Tech team, you will work with quality and compliance together with our clients in and around Gothenburg. The assignments can include quality management systems, batch review and release, deviation and CAPA handling, change control, audits and inspections, supplier quality, validation support and continuous improvement of the way quality is assured.

Assignments span pharmaceutical, biotechnology and medical device environments, from GMP manufacturing to medical device development. Depending on the assignment, your work may include:

• Writing, reviewing and improving SOPs, quality documentation, batch records and design history files.
• Leading deviation investigations, root cause analysis, complaints and CAPA processes through to closure.
• Preparing for and supporting internal audits, supplier audits, notified body assessments and regulatory inspections.
• Managing change control and maintaining the quality management system in line with applicable quality standards.
• Reviewing batch documentation and supporting product release and disposition.

We would be glad to see experience with EU GMP, GxP, medical device quality and risk management standards, batch review and release, deviation and CAPA systems, or electronic quality management systems.

Requirements for the role:

• An academic degree in life sciences, pharmacy, chemistry, engineering or a comparable discipline.

• Experience with in quality assurance, quality engineering or compliance in a regulated industry.

• Working command of at least one major quality framework within pharmaceuticals or medical devices.

• Experience of batch review and release, deviation handling, CAPA, change control or audit preparation.

• Strong communication skills, and the integrity to hold your position when it is inconvenient.

• English spoken and written fluently at a professional level. Swedish is considered a merit.

To fit this role, you will be proactive and have a strong drive and commitment. You enjoy taking assignments through to completion and have an analytical and strategic mindset. You are used to working in a dynamic environment and have experience communicating at different levels within larger organisations.

In the role as an Employeneur, you get to develop your technical expertise while also driving your own development and business. You become part of an innovative and entrepreneurial organisation where the focus is on continuous development and the opportunity to take full responsibility for steering your own career.

We place great importance on your personal commitment. You influence which projects you take on and which competence development you invest in. Quite simply, you steer your own career.

Since TMC is an international company, we can offer projects in the countries where we and our clients are present:
Sweden, the Netherlands, Belgium, France, Luxembourg, Spain, Portugal, Italy, Hungary, U.A.E., the USA and Canada. The world is your workplace!

We are currently on holiday, but we look forward to handling your application in August when we are back.