Details
Job Description
Description
Responsible for IT QS&CSV tasks to ensure efficient and effective common IT regulations and IT Quality Management processes/ systems are in place and are monitored within the global Quality IT function, and to drive IT CSV with legal and regulatory requirements as well as with corporate compliance policies where applicable in the Computerized systems in the global/regional IT functions (e.g. Cloud Native Computing, segregation of duties). Support overall Quality oversight and CAPA tracking for the global/regional IT functions.
Duties & Responsibilities
IT Quality Management Systems:
- Ensure implementation and monitoring of effective and efficient quality related IT processes (e.g. during implementation of new systems/services)
- Communication with global Quality and Compliance Business Functions and for meeting business quality and compliance needs
- Foster a culture of quality and compliance for the global/regional IT functions IT Computerized Systems Validation:
- Compliance sign off for SLC activities related to IT infrastructure qualification and validation of application systems used in the global/regional IT functions (e.g. change control, risk assessment, testing etc.)
- Ensure compliance with legal and regulatory requirements, and industrial standard (e.g., GAMP5)
- Provide compliance trainings (GxP) and therefore ensure awareness and communication to IT personnel (e.g., during implementation of new systems/services) Audits, Self-Inspections & IT Supplier Audits/Assessments
- Support/coordinate IT related internal/external audits
- Conduct Self-Inspections according to plan
- Perform external IT supplier audits/assessments (Third-Party Supplier Audits)
- Timely follow-up on implementation of agreed corrective actions IT QS&CSV Consulting:
- Perform proactive, effective consulting and coaching to support Validation/Qualification activities
Job Requirements
Requirements
Experience
- 2-3 years hands on experience in development and/or operational support for Application systems and/or IT Infrastructure systems
- 2-3 years hands on experience in Quality Management System, Auditing or IT Governance
- 2-3 years working in global business environment
Technical skills
- Ability of Information Technology
- Ability to follow processes and to generate good documentation
- Associate degree (and/or Certification) in Computer Science or related field
- Knowledge of the regulated environment (e.g. GxP, audits)
- Knowledge of Quality management systems (e.g. GAMP) and IT standards (e.g. ITIL)
- Fluency in oral and written English (mandatory). Additional language skill is preferred (e.g., Chinese, Japanese)
Soft Skills
- Teamwork
- Ability to build consensus and influence decisions
- Strong learning motivation
