Description
Details
Job Description
General Expectations
The IT QS & CSV Specialist is expected to support the internal team by assisting in maintaining and monitoring IT Quality Management processes and IT systems. This role provides data and support to check compliance with legal, regulatory, and corporate policies on a global level and for globally used systems.
Description
Support IT QS & CSV tasks to assist in maintaining efficient and effective common IT regulations and IT Quality Management processes/systems within the global Quality IT function. Provide data and support to ensure IT CSV aligns with legal and regulatory requirements as well as corporate compliance policies where applicable in the Computerized systems in the global/regional IT functions (e.g., Cloud Native Computing, segregation of duties). Assist in overall Quality oversight and CAPA tracking for the global/regional IT functions.
Duties & Responsibilities
IT Computerized Systems Validation:
- Support 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.).
- Assist in ensuring compliance with legal and regulatory requirements, and industrial standards (e.g., GAMP5).
- Provide support or data for compliance trainings (GxP) to ensure awareness and communication to IT personnel.
IT QS&CSV Consulting
- Provide an effective technical consulting and to support Validation/Qualification activities.
- Assist in the implementation and monitoring of quality-related IT processes (e.g., during the implementation of new systems/services).
- Provide data or reports to support IT-related internal/external audits/Self-Inspections.
- Assist in the technical follow-up on the implementation of agreed corrective actions.
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 working in global business environment.
Technical skills
- Knowledge of Information Technology.
- Ability to follow processes and 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 skills preferred (e.g., Chinese, Japanese).
Soft Skills
- Teamwork
- Ability to build consensus
- Strong learning motivation
- Supportive attitude, agility, and determination to assist in achieving goals.
Requirements
Please refer to job description.