Computerized System Validation
hace 7 meses
With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we’re in shapes our lives, we are advancing dermatology for every skin story.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
Further supporting our growth and innovation momentum, we are establishing a new Global Capability Center in Barcelona to deploy new capabilities to effectively support its global commercial and functional teams. Located in the upscale Eixample District in the heart of Barcelona, Galderma’s Global Capability Center offers numerous possibilities for professional development such as exposure to global and cross-functional projects and access to global career opportunities.
**Job Description**:
Within the Global Quality System department, the Validation Lead specific mission are to:
- Scope, plan and lead validation activities to ensure that Global IT systems are implemented in a validated status ensuring compliance with GxP regulations and Galderma policies.- Perform oversight of the CSV domain.- Provide CSV training to projects teams.
Key Responsibilities- Validation execution; Lead the CSV work for all projects in the Global IT portfolio with support of internal and external resources.- Report CSV Status for the on going projects- Based on IT roadmap and project portfolio forecast the CSV resource needs and cost- Monitor external suppliers’ performance and cost.- Contribute to improving the CSV methods applied in Galderma, (SOPs, INS, Trainings, Systems support....)- Provide CSV training
Skills & Qualifications- University/Business degree in relevant area IT, Chemistry, Pharmacy, Biology, or related science or technical field.- Demonstrate proficiency and thorough knowledge of computer system validation (CSV) and Data Integrity requirements defined by applicable health authorities and/or industry groups.-
- Thorough knowledge of regulatory requirements (FDA, EMEA, ICH...)- Strong background in the Pharma/Medical device industry in an international environment- Demonstrate skills of working under pressure- Strong analytical competences- Coordination and influencing skills
What we offer in return- You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.- You will receive a competitive compensation package with bonus structure and extended benefit package- You will be able to work in a hybrid work culture- You will participate in feedback Loops, during which a personalized career path will be established- You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take on accountability
Process steps- Send your CV in English- If your profile is a match, we will invite you for a first virtual conversation with Talent Acquisition- The next step is a virtual conversation with the hiring manager- The final step is a panel conversation with the extended team
Our people make a difference
At Galderma, you’ll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.
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