Are you looking for an opportunity where you can make a real impact, take ownership, and grow within Quality? As part of the continued development of our Quality function, we are now looking for an Operational Quality Specialist who wants to contribute with expertise, structure, and a hands-on approach to daily QA activities. In this role, you will play an important part in ensuring efficient and compliant quality operations while supporting the ongoing development of the department.
About Medical Valley
Medical Valley is a Nordic pharmaceutical company focused on the distribution of high-quality generic medicines. With a strong presence across several European markets, the company is dedicated to improving access to affordable healthcare through sustainable partnerships, high standards, and efficient pharmaceutical solutions. Medical Valley specializes in substitutable generic products and serves both tender-driven and commercial healthcare markets.
Medical Valley is part of the Xiromed division within the global pharmaceutical group Insud Pharma. With more than 45 years of experience and operations in over 50 countries, Insud Pharma offers the strength, expertise, and international reach of a well-established organization. The group covers the entire pharmaceutical value chain, including research and development, manufacturing, commercialization, and distribution of active pharmaceutical ingredients (APIs), generic medicines, branded pharmaceuticals, and biopharmaceutical products.
Role Overview
This is an exciting opportunity for a structured and hands-on QA professional who wants to take ownership of key operational quality activities in a growing and developing Quality organization. In this role, you will be responsible for managing and coordinating daily QA processes, including quality agreements, deviations, change controls, complaints handling, documentation, and QA-related reporting. You will also support audits, contribute to the development and maintenance of the Quality Management System, and participate in continuous improvement initiatives. The role involves close collaboration with internal stakeholders and offers the opportunity to make a visible impact in an international environment.
The position is based in Sweden and reports to the Quality Manager.
Key Responsibilities
Manage and coordinate daily QA processes, including quality agreements (drafting, review, follow-up)
Handle product quality complaints, deviations, change controls, and FMD-related activities
Own and drive the Change Control process, ensuring efficient coordination of assessments, tasks, and timely closures across functions
Ensure structured and compliant execution of Change Control in systems
Ensure timely and compliant execution of operational QA tasks
Monitor and manage QA-related inboxes (e.g. quality and complaints)
Maintain documentation, including archiving and registration of quality records
Support audit preparation, participation, and follow-up
Prepare and maintain QA reports, metrics, and overviews
Support implementation and maintenance of the Quality Management System in line with EU-GxP
Participate in projects and continuous improvement initiatives
Collaborate with internal stakeholders to ensure smooth and efficient daily quality operations
Personal Attributes
You are a structured and hands-on professional with strong attention to detail and a natural ability to create order in daily operations. You enjoy coordinating tasks, following up on activities, and ensuring that work is completed in a timely and compliant manner. With a collaborative and solution-oriented mindset, you communicate clearly, work effectively across functions, and thrive in a role where you combine quality focus with operational drive.
Education and Experience
Bachelor’s or Master’s degree in Engineering, Life Science, Pharmacy, or a related field (flexible depending on experience)
3–5 years of experience in QA, preferably within the pharmaceutical or life science industry
Experience working with operational QA processes such as deviations, change control, complaints handling, quality agreements, and documentation management
Technical Competence
Good understanding of EU-GxP requirements
Experience working with quality systems, documentation, and controlled processes
Ability to manage and coordinate QA activities in a structured and compliant way
Experience with QA reporting, follow-up, and audit support is an advantage
Fluent in English (written and spoken)
Swedish is a strong advantage
Additional Information
Location: Sweden (Höllviken area)
Occasional travel may be required
In this recruitment we are working with Management Partners. Please contact [email protected] 0761-199309 or [email protected] 0708-391232
