Validation Specialist

Oriola is a health and wellbeing company operating in the Nordic countries - Our Purpose is Health for Life and we are now strengthening our organisation!


About Oriola
We help people to live healthier lives by giving them access to sustainable health and wellbeing products and services. In Sweden, Oriola owns the country’s third-largest pharmacy chain, Kronans Apotek. In addition to pharmacies, our dose-dispensing, medical information and patient support services, we enhance the safety and effectiveness of pharmaceutical care. Our expert services support pharmaceutical companies throughout the entire lifecycle of medicines. Oriola’s supply chain ensures reliable and safe delivery of pharmaceuticals to pharmacies, hospital pharmacies, veterinarians and other healthcare operators. In 2019, Oriola Corporation’s net sales were 1.7 billion euros and we employed nearly 4,300 professionals. Oriola Corporation is listed on Nasdaq Helsinki. www.oriola.com
We are looking for a

Validation Specialist

for the quality organisation of Oriola’s Business Area Pharma. Our quality organisation has a total of approximately 20 employees in Finland and Sweden. It is responsible for monitoring, follow-up and training regarding the compliance with GxP requirements and obligations governing our company’s operations, as well as providing support for our business operations as needed.

 The Validation Specialist will work in a permanent position as a member of Oriola's quality organisation either in Finland (Espoo) or in Sweden (Mölnlycke, Enköping or Stockholm) and will report directly to the Quality Director. The Validation Specialist will be involved in all aspects of computer systems validation (CSV) and qualification within a GxP regulated environment.

 As a Validation Specialist in the QA, your duties will include e.g.


• planning, coordinating and executing computerized system validation activities in the Quality team, and in close co-operations with IT, according to the quality system within the framework of test plans, guidelines and routines
• validation lead role in projects, where applicable
• preparation of validation master plan (VMP) and coordination of its execution in collaboration with organization’s other functions
• compilation, review, execution and/or approval documentation for validation and qualification work
• assessment of potential risks
• ensuring compliance and maintenance of validated status of systems
• participation to external service provider audits/evaluations and internal audits
• providing recommendations and training regarding validation and qualification approaches
• investigation and troubleshooting validation problems
• contribution to development of validation methodologies, procedures, practices and documentation in co-operation with other specialists

 To be successful in this role we expect you to have:


• Master’s degree in the field, such as engineering or other relevant industry management
• minimum of 5 years´ of experience in similar or equivalent role, preferably in a Quality environment with exhibited knowledge and proficiency of requirements for implementing, validating, and maintaining computerized systems within GxP regulated field
• a precise and systematic approach to work, the ability to work both independently and as part of a team
• project work experience and capacity to work in an international environment
• good knowledge of GxP requirements and other relevant legislation and guidelines
• excellent verbal and written communication skills
• excellent cooperation and coordination skills
• Fluency in written and spoken English, Finnish or Swedish is qualifying
• willingness to travel in Nordics

Auditing experience and project management experience are considered an asset.

You are active, cooperative and have a positive attitude towards development. You are analytical, accurate and structured. You know how to prioritize and handle several projects concurrently and still meet deadlines. You are well versed in regulatory requirements and understand business requirements, and you are capable of developing our operations accordingly.

At Oriola, we cherish openness, taking initiative, responsibility and working together. If you share these values and are interested in the role, please apply latest by December 4th via https://www.oriola.com/careers/open-vacancies/ with your application letter, CV and salary request. We will start recruitment interviews with the applicable candidates already during the application period. We hope to hear from you soon!

For further information, please contact Quality Director, Päivi Ylä-Kotola, Tel. +358 (0)40 720 1526, available on Friday 20.11. 2020 at 10-12 (Fin time) and Tuesday 24.11.2020 at 10.00-12.00 (Fin time).