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Msat Continuous Improvement Statistician - Rosia, Italia - GSK

GSK

Azienda verificata

Rosia, Italia

1 mese fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

Site Name:
Italy - Rosia

Posted Date:
Aug

Scopo dell'attivitå:

He/She works in a team of scientists, engineers, and/or other professional employees with acknowledged and deep technical know-how. Accountable for providing timely data-trending and statistical analysis of critical parameters, ensuring processes are robust and continuously improving.

Main goal of his/her team is: strongly contribute and driving energy to assure robust manufacturing processes and materials in place at Rosia site, timely monitored in their performances and continuously improved.

Areas of competences:

Primary Operations (seed banking, upstream, and downstream) running at Rosia site. Competences are on drug substances (bulks) and bacterial seed-bank.

Aseptic Operations (formulation, filling, and visual inspection) running at Rosia site. Competences are in sterile and final-products.

Descrizione dell' attivita':

Partner with Process Science and MPUs to provide Multivariate Data Analysis on process outputs for the improvement of commercial processes in alignment with the QbD principles.

Ensuring high quality regulatory dossiers which set the benchmark in the industry and result in high regulatory acceptance

Ensure state-of-the-art Continued Process Verification (CPV) is assured (by means of modern statistical analyses) to: (i) deepen and broaden process understanding and knowledge; (ii) detect issues in process capability, such as systematic quality defects; (iii) Identify trends of process deviations (e.g.

deviation with common root cause); (iv) Issue quarterly/annual datatrending report; (v) ensure data and trending are visible and communicated at shop-floor level, and reflected into official documentation too (e.g., APR).

Provide reports in compliance with current guideline ICH/FDA and local-global procedure

Cooperate actively cross-sites and cross-departmental within GSK vaccines to develop, align, standardize data evaluation method, methodologies and convention.

Contribute to local ang global guideline documents with statistical content

Ensure compliance with regulations and company standard operating procedures (SOPs) about environmental health and safety (HSE), contributing to protect and to guarantee safety of all employees, customers and environment.

Conoscenze professionali/ tecniche:

Education (minimum/desirable): University degree in Statistics, Mathematics, (theoretical) Physics Computer Science or comparable experience

Languages:
Fluent in English and proficient in site local language.

Desired/expected skills:
Communication skills

Problem Solving & Innovation

Strong attitude towards cross-site, international and multi-cultural environment

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive.

Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people.

While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.

We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy.

We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

GSK is an Equal Opportunity/Affirmative Action Employer.

All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

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 GSK's Transparency Reporting For the Record site.