GSK

Data Integrity Specialist

GSK  •  Gödöllő, HU (Hybrid)  •  2 hours ago
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Job Description


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.

Why You?

Basic Qualifications & Skills:


- 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.

Preferred Qualifications & Skills:

- 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.

What we offer:

  • Hybrid working model with a mix of 2 days on-site presence and 3 days working in HO. Exact on-site schedule will be discussed during hiring.

  • A collaborative and supportive team that values learning and development.

  • Opportunities to lead projects that improve quality systems and digital ways of working.

  • Cafeteria package

  • Annual bonus and annual salary review

  • Group life and accident insurance package

  • Voluntary pension fund contribution

  • Health and wellbeing services

  • Inclusive, diverse, and supportive company culture

  • Commuting support (company shuttle buses from Budapest and surrounding towns or fuel reimbursement for private car usage)

  • Permanent employment contract

  • Paid parental leave and caregiver leave

Skills

Data Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Pharmaceutical Regulatory Compliance, Problem Solving, Quality Assurance (QA), Risk Awareness, Technical WritingHungarian Salary Range / Magyarországi bérsáv: HUF 12,132,000 to HUF 20,220,000The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.A pozícióra felvett új munkavállalók éves bruttó alapbére a fenti bérsávok szerint alakul az egyes érintett lokációknál. Ezek a sávok több tényezőt is figyelembe vesznek, többek között a jelölt készségeit, szakmai tapasztalatát, iskolai végzettségét, valamint az adott munkakör piaci bérszintjét. Ezen felül a pozíció éves bónuszra is jogosíthat, valamint részvételt biztosíthat a részvényalapú hosszú távú ösztönző programunkban, amelynek elérhetősége a pozíció besorolásától függ. A teljes juttatási csomagra vonatkozó részletesebb információkat a toborzási folyamat során biztosítjuk. Ez a munkakör több helyszínről is betölthető, ezért egyes országok esetében a releváns bérsávok is feltüntetésre kerülnek. Más helyszínek bérsávjai azért szerepelnek az álláshirdetésben, mert egyes piacokon a bértranszparenciára vonatkozó jogszabályok előírják a fizetési információk közzétételét. Ezek a helyszínek potenciális munkavégzési lokációk lehetnek ennél a munkakörnél. Amennyiben egy adott országra, vagy helyszínre vonatkozóan nem szerepel bérsáv az álláshirdetésben, a vonatkozó kompenzációs feltételekről a toborzási folyamat során lesz szó. Kérjük, vegye figyelembe, hogy a fizetések országonként eltérhetnek a jelölt készségei, tapasztalata, iskolai végzettsége és az adott munkakör piaci bérszintje alapján. Az ajánlatok jellemzően a meghirdetett bérsávon belül kerülnek meghatározásra a jelölt készségei, tapasztalata és képesítései alapján, míg a sáv felső értéke általában a kiemelkedően tapasztalt jelölteknek vagy egyéb, e kritériumokkal összhangban álló kivételes eseteknek van fenntartva.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Should you require any specific adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on hu-inclusion.recruitment@gsk.com

Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels’.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

GSK

About GSK

We are uniting science, technology and talent to get ahead of disease together.

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Industry
Chemicals & Materials
Company Size
10,000+ employees
Headquarters
London, GB
Year Founded
Unknown
Website
gsk.com
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