Global Csv Ot Manager
2 semanas atrás
Job Description:
At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women’s health, gastroenterology and urology. Ferring + You is all about working together and sharing ideas, so that we can bring science to life for patients around the world.
Every person at Ferring works together to change lives and help people build families. Our corporate teams offer empowering, innovative, challenging and rewarding careers - we are motivated to make a difference. To reach our full potential we collaborate, and respect and value diverse contributions so that we can grow as an organization and as professionals. Together we can influence the world around us to make life and work better.
Ferring+You
The Computer System Validation (CSV) Manager is accountable to deliver an efficient global and compliant validation strategy for multi-site as well as local projects/programs/significant changes implementation of OT (Operational Technology) solutions. Ensure that the validation strategy, roles & responsibilities between global and local functions and personnel are clear and understood to ensure compliance of all OT GMP systems and answer accurately to any questions from health authorities. Maintain the validated status of OT solutions across all manufacturing sites.
You will report to the Head of Operational Technology. Based in Lisbon, you will partner with colleagues also located in our new corporate office in Lagoas Park as well as our global OT Solutions team who are located all over the world.
Your day at Ferring- Maintain the validated status of global OT Systems and Applications with the system owner(s) and the local CSV experts.- Ensure that Computer System Validation (CSV) related CSOPs are understood and implemented for OT Systems and Applications. Any required changes to the existing validation approach for OT Systems and Applications must be carried out (i.e.: updating existing documentation or adding new documents according to a change in the related CSOPs). Work with the authors of the CSOPs to ensure that any specific validation requirements covering the implementation and operation of OT Systems and Applications is considered.- Accountable to define the validation strategy for new OT project implementations and upgrades, ensuring easy ongoing maintainability for routine changes or where changes are expected to be more frequent (i.e.: splitting the validation documentation for each interface and for each custom-made user screen).- Responsible to create the global CSV documents templates to support new OT project implementations according to the validation strategy and provide support to local CSV experts whenever required during global project execution.- Ensure that the validation documentation and the structure of global OT Systems and Applications are well understood and implemented by the manufacturing sites, so they can be independent during health authority audits.- Enforce the use of electronic systems for testing (i.e.: RQM) and ensure similar testing structure among projects.- Where applicable enforce and support the regression testing using automated testing tools.- Participate in the assessment of system reviews, deviations, CAPA, Changes, continuous improvement and troubleshooting related to Global OT Systems and Applications.- Establish and lead the process/framework to monitor compliance adherence of OT Systems and Applications both globally and locally with the sites.-
- Guide and support sites during health authority inspection as required, e.g. describing the validation approaches across multiple sites, expert input into questions related to CSV, etc.
Behind our innovation There’s you- Bachelor's degree with a preference in Computer Science or related field. Master’s degree preferred- Min 10 years’ experience in an operational IT/OT/Automation position with a good understanding of pharma, chemistry, food industry within industrial company- Min 5 years of experience of CSV projects and computer validation methodologies.- Min 5 years of experience in writing, reviewing and executing CSV documentations (IQ, OQ, PQ)- Very good knowledge of PLC, SCADA, Historian, Data Collector implementation- Strong analytical & problem-solving skills- High commitment and result oriented- Good communication, good leadership, organised & proactive approach- Teamwork and customer oriented- Fluency in English, other languages will be a plus
People come first at Ferring- Get inspired from our commitment to advocate for everyone’s right to build a family, no matter who you are, where you live or who you love- Our inclusive support package - “Building Families at Ferring” provides equal and accessible policies for all employees who wish to start their family journey, ensuring a global standard, irrespective of location and role- Parent
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