IT Quality Systems and CSV Specialist | Pharma (100% Remote)

Would you like to work in a global, multicultural team as "IT Quality Systems and CSV Specialist" for a committed international pharmaceutical company?

If improving the quality and efficiency of IT systems and processes is in your DNA, we encourage you to sign up for this offer.

TASKS & RESPONSIBILITIES🚀:

• Ensure IT Quality & Compliance activities are effectively implemented and monitored across the global IT function.

• Support compliance with applicable regulatory requirements and corporate policies within the IT environment.

• Provide Quality & Compliance oversight for IT infrastructure qualification and computer system validation activities.

• Review and approve key SLC deliverables, including change controls, risk assessments, testing documentation, periodic reviews, and exception management.

• Ensure compliance with CSV, electronic records, electronic signatures, and data integrity requirements.

• Implement and monitor IT quality processes, including support during self-inspections.

• Collaborate with global Quality and Compliance teams to address business quality and compliance needs.

• Promote a culture of quality and compliance across the IT organization.

• Deliver GxP and non-GxP compliance training and drive awareness among IT personnel.

• Monitor adherence to corporate IT policies, procedures, SOPs, and work instructions.

• Coordinate and support internal and external IT audits and inspections.

• Conduct IT quality assessments and self-inspections, and monitor the effectiveness of CAPA actions.

• Provide proactive quality and compliance guidance to support validation and qualification activities.

REQUIREMENTS 🤹:

• Fluent in written and spoken English.

• Master's degree in computer science, biotechnology or related field.

• Several years of experience with quality management systems (e.g. GAMP) and IT standards (e.g. ITIL).

• In-depth knowledge of the regulatory environment (e.g. GxP, audits) and information technology.

• In-depth knowledge of GxP-relevant IT processes and their support by computerized systems.

• Excellent communication skills, analytical thinking and the ability to work in a spirit of partnership.

• Ability to build consensus and influence decisions.

SCHEDULE 🕘:

• From Monday to Friday: 08 am to 17 pm / 09 am to 18 pm (flexible)

• Possibility of 100% Remote work.

BENEFITS🌱:

• Salary package based on your profile. We will discuss it on our first call.

• Permanent Contract.

• Ticket restaurant included if you go to the office.

• Flexible Retribution Program (medical insurance, public transport ticket and childcare check).

• Discounts on gym network (Wellhub)

• Learning & Development.

  Our goal is that you are well in every way!