Data Integrity Expert

Location: Miskolc, Hungary

Flexible working: Hybrid

Job type: Permanent, Full time

About the job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

As a Data Integrity Expert you will be responsible for to identifying, managing, and reducing risk level of the Data Integrity of GxP, ensuring the valid state of GxP computerized systems throughout their entire lifecycle.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities:

• Ensuring compliance with regulatory requirements and company policies related to data integrity.
• Conducting regular routine data quality checks and validations to identify and address any data integrity issue.
• Developing and delivering training programs on data integrity principles and practices.
• Identifying and assessing risks related to data integrity and implementing mitigation strategies.
• Ensuring proper documentation practices are followed, including data recording, storage, and retrieval.
• Investigating data integrity incidents, including potential data breaches or falsification incidents, and implementing corrective and preventive actions (CAPA).
• Leading continuous improvement initiatives to enhance data integrity practices.
• Overseeing the validation of computerized systems to ensure they meet data integrity requirements
• Ensuring inspection readiness and participating in regulatory inspections and audits related to data integrity.
• Generating and reviewing data integrity reports and metrics for management, especially the DIMM (DI Maturity model)

About you

Experience:

• Experience in ensuring compliance with regulatory requirements related to data integrity in the pharmaceutical industry.

Hard and soft skills:

• Knowledge in Quality Assurance regulations
• Deep understanding of GxP computerized system validation (including GxP infrastructure qualification) as per ISPE GAMP5 guideline.
• Expertise in using and validating computerized systems and software relevant to data integrity management.
• Strong critical thinking skills.
• High level of accuracy and attention to detail in data recording, auditing, and reporting.
• Strong verbal and written communication skills to effectively train staff, report findings, and collaborate with various departments.

Education:

• Master degree: mechanical, IT or other engineering fields preferred

Languages:

• Hungarian – full professional proficiency in verbal and written
• English – communication level in verbal and written  

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

If the description fits your experience and sparks your interest, we warmly invite you to apply and explore the opportunity further with us!

If you know someone who would be a great fit, please click on the 'refer' button and help them take their next career step.

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