Global Power User Paperless Validation (f/m/x)
Better Health, Brighter Future
Als weltweit führendes biopharmazeutisches Unternehmen haben wir tagtäglich das Ziel, uns getreu dem Unternehmensmotto "Better Health, Brighter Future" in den Dienst des Patienten zu stellen. Das Herzstück dafür bilden engagierte KollegInnen. Wir erweitern unser Team und suchen:
Global Power User Paperless Validation (f/m/x)
About the role:
As Global Power User for the paperless validation system (Kneat), you bring an extensive knowledge and leadership in validation. You will drive the day-to-day operational maintenance and continuous improvement and support with the global deployment. In this role you will work in close cooperation with multiple business units and ensure that business requirements are met. You will support the site power users and organize and maintain the CoP of the system.
How you will contribute:
- Leading and interface with cross-functional team members (Engineering, Manufacturing, Regulatory Affairs, Quality Operations, Quality Validation, Supply Chain, and other technical disciplines) representing the respective validation elements, as applicable
- Translating industry standards (GMPs, FDA Guidelines), procedures, and regulatory requirements such as but not limited to (21 CFR Parts 210, 211, 600, ISO 14644, EC-Annex1, etc.) into business requirements
- Reviewing and assessing change control requests with potential impact to validated state of validation elements
- Providing training, mentoring and leadership to less experienced colleagues
- Monitoring and supporting validation efficiency program on global level
- Guiding peers in Validation and Engineering Departments to use best-in-class qualification Engineering approaches
- Identifying opportunities for an optimized process within the tool
- Driving and closing gaps related to validation requirements and in adherence to global Validation framework
- Participating and supporting in internal or external assessments or audits
- Presenting a course of action to the management or a validation strategy and protocols in regulatory inspections
- Leading and participating in the drafting and implementation of Global procedures including initiatives for harmonization and streamlining efforts
What you bring to Takeda:
- At least Bachelor degree preferably in the engineering or science field
- A vast experience, proficiency and leadership in pharmaceutical/biotech validation which includes the writing and executing of protocols and standard operating procedures
- Profound experience in manufacturing processes and control systems, cleaning processes, process equipment, facilities and GMP critical support systems
- Proficient Subject Matter Expert (SME) in (all) validation elements
- In depth Knowledge of the Kneat application
- Excellent organizational skills and ability to analyze, plan and implement resolutions to technical problems
- Familiarity with auditing techniques, interpreting regulations and quality systems
- Exceptional interpersonal, communication, influencing and negotiation skills
What Takeda can offer you:
A competitive remuneration package with a minimum salary of € 4.527,78 gross per month (full-time, collective wage agreement for the chemical industry) - the actual salary depends on your professional experience and qualifications.
- Family-friendly company environment; Support with parental leave, dad month, Bilingual company kindergarten
- Work @ home depending on the position / department
- Comprehensive training programs
- In-house job rotation program
- In-house Canteen with discounts or meal vouchers
- Works council (events, festivals, shopping vouchers, etc.)
- Employee Referral Program
- Employee Recognition Program
- Takeda Resource Groups
- Medical checkups
- Free vaccination program
- Fitness Center
- In-house cleaning service
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.
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