Quality Specialist

Tepsivo; Helsinki; Remote; EUR 40 000 - 60 000; Full time

Job description

(Full Remote or Prague / Helsinki-based)

Tepsivo is a young company on an ambitious mission to reshape the world of Pharma and pharmacovigilance into a modern-day industry. Since our conception in 2020, we’ve become the world’s first fully digital global drug safety provider, with a genuine end-to-end PV system run by our in-house developed tools.

We’re looking for a Quality Specialist who is ready to take on the challenge of helping us remain in compliance while ensuring that the operations run efficiently without excess bureaucracy.

While doing this, you get the chance to make a dent in the PV services industry that has so far been dominated by dinosaurs relying on obsolete business models with low value-added activities and manual labor-intensive processes.

It’s high time for a change, and that’s what we’re here to do. Are you?

What is your ideal background?

Minimum 2 years experience in pharmaceutical or medical device development/manufacturing, pharmaceutical or medical device safety/pharmacovigilance/post-market surveillance or other regulated field with focus on quality.

What do we expect you to do?

As the Quality Specialist, we expect you to have excellent attention to detail, a systematic approach to working, the ability to balance priorities according to due dates, and a problem-solving attitude.

We expect you to be an innovative thinker comfortable with implementing new types of processes and the use of smart technology. You should have the ability to work independently and collaboratively and assume complete accountability for all your activities. Last but not least, you should be able to operate in a highly regulated environment requiring full documentation of all performed activities.

As the Quality Specialist, you will report directly to the Director of Quality Management.

General areas of responsibilities:

1. Audit/inspection management
   • Scheduling and keeping audit schedule up-to-date with possible changes
   • Preparation for audits (including meeting arrangements), compiling documents for pre-audit document requests, and cooperating with SMEs for obtaining documents as needed
   • Managing ad-hoc document requests and maintaining records for audit documents
   • Recording audit findings, assigning them to SMEs, and monitoring closure of findings
2. Document control
   • Assist in maintaining an up-to-date list of controlled documents
   • Ensuring documents are periodically reviewed in time, tracking periodic review due dates, and recording periodic document review activities
   • Publishing of controlled documents, storage of documents in EDMS and learning management system
   • Managing training requirements, courses, and groups
   • Maintaining information about the effectiveness of approved documents
   • Obsoletion of old versions of documents in EDMS and learning management system
3. CAPA management
   • Monitoring creation, assessment, and completion of actions related to closing CAPAs
   • Ensuring CAPA description and related findings match
   • Follow-up with assigned staff
   • Maintaining up-to-date status of CAPAs
4. Other duties as assigned.

We’re a modern company and believe in a decentralized approach to management. This means we are strong supporters of providing enough freedom on where you work as well as how.

Your boss will not look over your shoulder every day. Instead, you will have transparent access to key company data and objectives, and we will expect you to make informed decisions on the areas of your responsibility. In return, we expect you to be fully accountable for your own work, good or bad.

This can only work with people of the right talent and those who genuinely share our values and philosophy. Tepsivo solutions have removed, automated, or otherwise digitized routine PV activities and what is left is value-added work requiring a strong skill set. If you’re selected to work at Tepsivo, that means you’re already among the best of your peers, and that is something we hope to foster and reward accordingly.

If you’re ready for a true challenge, then let’s talk.

Submit your CV and don’t forget to add your cover letter so we understand what motivates you about this opportunity.