Validation Specialist (Computerised Systems)
Job Title: Validation Specialist (Computerised Systems)
- To coordinate and organize computerized system validation activities of Computerised Systems and Lab/Production Equipment according to DI requirements.
- To prepare and/or to check validation plans and protocols.
- To prepare and/or to check validation reports by evaluating results which are obtained from executions.
- To determine and to follow up requirements which belong to validation activities and data integrity requirements.
- To perform the situation analysis for the validation activities to be done within Quality Assurance System and to use these validation requirements in the preparation of annual plans and validation master plan.
- To prepare and to coordinate the preparation of annual plans for the activities of Computerized Systems and Lab/Production Equipment.
- To follow up the monthly realizations for the validations under his own responsibility.
- To ensure the preparation of Annual Validation Master Plan with the relevant departments.
- To perform the required controls and monitorings in order for the validation activities to be executed within the direction of the plans by coordinating and organizing the validation activities.
- To make DI assessment for Computerised Systems (Lab/Production Equipment) to be established and to perform follow up.
- To determine the systems / equipments / devices to be verified with the relevant departments.
- To deliver his own opinion upon determining the requirements of the validation.
- Projects ; In cooperation with responsibles of related departments he / she joins to projects as a validation responsible of the project. Cooperates on projects regarding GxP systems with the objective of meeting GXP/Data integrity requirements. Takes place in IT Projects and New Lab/ Production Equipment Projects. Plans the validation activities and gives some help for completing the validation activities as a member of the team.
- To give technical support regarding his/her own issues,consultancy and expertise, which are required in the company, regarding his/her own issues.
- To plan the jobs regarding his/her department and to carry out the necessary arrangement in order for these jobs handled smoothly.
- Informs the out of limit situations and deviations occurred in the validation activities and data integrity activities and submits own solution proposals.
Background & Experience
- Bachelor's Degree in Chemical Engineering or Chemistry.
- Minimum 5 years of experience in pharma validation.
- Experience for computerized system validation in pharma industry having huge equipment and system inventory.
- Good ability to use MS Office programs (especially Word and Excel)
- Fluent in English both written and spoken
- Experience in performing periodic review activities for computerized systems and documentation.
- Follow up of data integrity gap actions and their documentation.
- To be familiar with good documentation practices
What Sanofi Can Offer You
- Benefits to enhance your life journey
- Development opportunities to own your future
- An open and inclusive environment where you can be yourself
- Social activities and wellbeing programs to support your life
We chase the miracles of science to improve people’s lives.
We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives.
Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to make the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our commitments.
We are one of the largest pharmaceutical companies in Turkey, serving public health for with more than 1,600 employees. Adding value to local economy and development in Turkey, we offer a broad range of products including innovative therapeutic solutions, biotechnological pharmaceuticals, vaccines, and consumer healthcare products.
Our factory in Lüleburgaz is one of the leading pharmaceutical manufacturing plants in Turkey. It is also among the top three Sanofi production sites worldwide in terms of its manufacturing capacity. Our manufacturing site produces high-quality pharmaceuticals in many different forms in accordance with global health standards, and develops generic medicine at its on-site R&D Center.
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles.
So, let’s be those people.
Let’s explore more, and share a purpose, as well as our skills. Let’s reinvent healthcare, chase change, and embrace new ideas. Let’s take bigger risks and find better solutions for the people we help.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.