Data Integrity Specialist

Hely: Gödöllő
Cég: GlaxoSmithKline Biologicals Kft.
Kategória: Egészségügy, Gyógyszeripar

As Data Integrity Specialist, You will lead data integrity activities to protect the completeness, accuracy and availability of quality and manufacturing data. You will work closely with site quality, IT, manufacturing and global quality teams. We value clear thinkers who act with integrity, who can teach others, and who enjoy improving systems and processes.This role offers growth through cross-functional projects, meaningful impact on product quality systems, and alignment with GSK’s mission of uniting science, technology and talent to get ahead of disease together.Responsibilities: - Being Single Point of Contact (SPOC) for any topic 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 (CAPA).- Deliver training and coaching for site colleagues to build data integrity awareness and good practices.- Participate in internal audits and support readiness for regulatory inspections. - Bachelor’s degree in a scientific, technical or engineering discipline, or equivalent experience.- Minimum 2–5 years’ experience in pharmaceutical quality, compliance, IT validation or related area.- Practical knowledge of Good Manufacturing Practice (GMP) principles and how they apply to data and records.- Experience assessing computerised systems, electronic records, or paper record controls.- Hungarian speaker with good English communication skills and ability to work with cross-functional teams. - Experience specifically 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, CSV (computerised system validation) or IQ/OQ/PQ activities.- Practical skills in risk assessment and root cause analysis for data issues.- Strong coaching and training experience to upskill site colleagues.- Fluent Hungarian and strong English language skills. Cafeteria packageHybrid working model with a mix of 2 days on-site presence and 3 days working in HOAnnual performance bonus and annual salary reviewGroup life and accident insurance packageVoluntary pension fund contributionHealth and wellbeing servicesInclusive, diverse, and supportive company cultureCommuting support (company shuttle buses from Budapest and surrounding cities or fuel reimbursement for private car usage)Permanent employment contractPaid parental leave and caregiver leave

Címkék: Employee status, University

profession.hu - kb. 17 órája

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