QA Manager, CS QA
Orion PharmaFinland2 hours ago
Full-timeRemote FriendlyQuality Assurance
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Job Description
About your role
We are looking for an experienced professional to join our Computerized Systems QA (CS QA) team as a CS QA Specialist. CS QA is part of Technical QA unit within the Quality System organization.
You will report to the Head of Technical and CS QA unit. Unit consists of 6 experts working in Espoo and Turku.
This is a permanent full-time position based in Espoo, Turku or in Salo with a hybrid work model in accordance with Orion’s working guidelines.
Your Key Responsibilities
We offer you an interesting and a highly versatile and engaging area of responsibility in the ever-evolving world of computerized systems at the heart of quality. Our work is driven by an uncompromising commitment to ensure that our practices comply with the current GxP requirements. At Orion, we strive for excellence, value each other, and build the future together.
At Orion, your work creates true impact and well-being for our customers, patients and society at large. Our culture of friendliness, respect, mutual appreciation and diversity creates a safe working environment where you can strive for excellence. We offer a wealth of career paths and development opportunities that support the development of innovative solutions and improving the quality of life.
Please visit our website to find further information about our values and Orion as an employer https://www.orion.fi/en/careers/orion-as-an-employer/ .
Our expectations
Interested? Please apply for the position as soon as possible, but no later than 05.11.2025. We process applications already during the application period.
For more information about the task, please contact Mika Kettunen, Head of Technical and CS QA, tel. 050 966 7134 (27.10. at 9-10 or 14-15, 31.10. at 13-14 and 03.11. at 09-10).
Approved medical examination which also includes drug testing is required prior to the employment. We will also carry out a security clearance prior to the employment for the selected person.
Unit Description
Quality management (QM) is responsible for ensuring the quality of materials, products and operations, as well as maintaining and developing the quality system and monitoring the regulatory environment. Pharmacovigilance and Patient Safety unit is responsible for the global pharmacovigilance system of Orion Corporation and for the continuous safety surveillance, regulatory reporting and safety risk management activities of human and veterinary medicinal and non-medicinal products.
The QM function consists of about 350 experts who work in Quality Control, Quality Assurance, Quality System, Method Development and the Pharmacovigilance & Drug safety unit. We are located in Espoo, Turku, Salo and Kuopio plants, in addition to the Quality Assurance team in India reporting dotted-line to QM.
About Us
Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years.
We’re home to more than 4,000 Orionees around the world, and we’re proud to be known as a responsible employer and a great place to work. At Orion Pharma, people are truly valued and trusted, encouraged to grow, and supported by a culture where every voice is heard. We appreciate each other, strive for excellence, and build the future.
Together we develop, manufacture, and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Our extensive portfolio includes proprietary and generic medicines as well as consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion Pharma are used to treat cancer, neurological diseases, respiratory diseases, and more.
We offer careers with a clear purpose: empowering people to live their lives to the fullest.
About your role
We are looking for an experienced professional to join our Computerized Systems QA (CS QA) team as a CS QA Specialist. CS QA is part of Technical QA unit within the Quality System organization.
You will report to the Head of Technical and CS QA unit. Unit consists of 6 experts working in Espoo and Turku.
This is a permanent full-time position based in Espoo, Turku or in Salo with a hybrid work model in accordance with Orion’s working guidelines.
Your Key Responsibilities
- Quality assurance activities related to computerized systems
- Interpretation of CS regulatory requirements
- Monitoring of pharmaceutical industry regulations and ensuring proper implementation
- Contributing to the development of validation policies for computerized systems and ensuring correct system maintenance in collaboration with the CS QA team and internal stakeholders
- Participating in authority and partner inspections
- Conducting internal and external audits of computerized systems and system vendors
- Creating and developing operational practices in cooperation with stakeholders.
- Act as a subject matter expert in tasks within the CS QA team's area of responsibility
We offer you an interesting and a highly versatile and engaging area of responsibility in the ever-evolving world of computerized systems at the heart of quality. Our work is driven by an uncompromising commitment to ensure that our practices comply with the current GxP requirements. At Orion, we strive for excellence, value each other, and build the future together.
At Orion, your work creates true impact and well-being for our customers, patients and society at large. Our culture of friendliness, respect, mutual appreciation and diversity creates a safe working environment where you can strive for excellence. We offer a wealth of career paths and development opportunities that support the development of innovative solutions and improving the quality of life.
Please visit our website to find further information about our values and Orion as an employer https://www.orion.fi/en/careers/orion-as-an-employer/ .
Our expectations
- A relevant university or university of applied sciences degree in a technical or natural sciences/mathematics-related field
- Strong experience and knowledge of computerized systems and GMP requirements in pharmaceutical industry
- Ability to develop quality processes for computerized systems in collaboration with stakeholders
- Good pressure resilience and ability to react judiciously in changing situations
- Excellent cooperation skills and ability to communicate and influence orally and in writing fluently in both Finnish and English
- Willingness to travel domestically and internationally
Interested? Please apply for the position as soon as possible, but no later than 05.11.2025. We process applications already during the application period.
For more information about the task, please contact Mika Kettunen, Head of Technical and CS QA, tel. 050 966 7134 (27.10. at 9-10 or 14-15, 31.10. at 13-14 and 03.11. at 09-10).
Approved medical examination which also includes drug testing is required prior to the employment. We will also carry out a security clearance prior to the employment for the selected person.
Unit Description
Quality management (QM) is responsible for ensuring the quality of materials, products and operations, as well as maintaining and developing the quality system and monitoring the regulatory environment. Pharmacovigilance and Patient Safety unit is responsible for the global pharmacovigilance system of Orion Corporation and for the continuous safety surveillance, regulatory reporting and safety risk management activities of human and veterinary medicinal and non-medicinal products.
The QM function consists of about 350 experts who work in Quality Control, Quality Assurance, Quality System, Method Development and the Pharmacovigilance & Drug safety unit. We are located in Espoo, Turku, Salo and Kuopio plants, in addition to the Quality Assurance team in India reporting dotted-line to QM.
About Us
Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years.
We’re home to more than 4,000 Orionees around the world, and we’re proud to be known as a responsible employer and a great place to work. At Orion Pharma, people are truly valued and trusted, encouraged to grow, and supported by a culture where every voice is heard. We appreciate each other, strive for excellence, and build the future.
Together we develop, manufacture, and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Our extensive portfolio includes proprietary and generic medicines as well as consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion Pharma are used to treat cancer, neurological diseases, respiratory diseases, and more.
We offer careers with a clear purpose: empowering people to live their lives to the fullest.
Key Skills
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