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GSK

Develops medicines, vaccines, and consumer health

Data Integrity Specialist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeGödöllő, Hungary

About the Job

Requirements

  • A bachelor's degree in a scientific, technical, or engineering discipline, or equivalent experience.
  • At least 2 years of experience in pharmaceutical quality, compliance, IT validation, or a related area.
  • Practical knowledge of Good Manufacturing Practice principles and their application to data and records.
  • Experience assessing computerised systems, electronic records, or paper-record controls.
  • Fluency in Hungarian and strong English language skills.

Responsibilities

  • Serve as the single point of contact for topics related to data integrity.
  • Maintain and drive the site data-integrity program to meet regulatory expectations and company standards.
  • Assess computerised systems and paper records for data-integrity risk, and support validation and change-control activities.
  • Write, review, and approve procedures, work instructions, and training materials related to data integrity.
  • Lead investigations of data-integrity issues and support corrective and preventive actions.
  • Deliver training and coaching to site colleagues to build data-integrity awareness and good practices.
  • Participate in internal audits and support readiness for regulatory inspections.

Desired Qualifications

  • Experience in data-integrity programs or audits in a regulated environment.
  • Knowledge of electronic quality management systems, laboratory systems, or manufacturing execution systems.
  • Hands-on experience with system validation, computerised system validation, or IQ/OQ/PQ activities.
  • Practical skills in risk assessment and root-cause analysis for data issues.
  • Coaching and training experience to upskill site colleagues.

About the Company

GSK

Develops medicines, vaccines, and consumer health

GSK is a global healthcare company focused on three main areas: Pharmaceuticals, Vaccines, and Consumer Healthcare. It develops medicines, vaccines, and consumer health products to improve health outcomes worldwide. Its products address diseases in respiratory, HIV, oncology, and immuno-inflammatory areas; vaccines for influenza, shingles, and COVID-19; and over-the-counter wellness products. The company relies on substantial R&D and strategic partnerships to bring new products to market and to address health needs. Revenues come from sales of medicines, vaccines, and consumer health items, often complemented by patient support programs and collaborations with governments and biotech partners.

Company size
10,001+
Company stage
IPO
Headquarters
London, United Kingdom
Founded
1891

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