IndirizzoDescrizione del lavoro:
Il Validation Specialist garantisce la compliance degli impianti di processo farmaceutici, mediante convalida documentata e adeguata al livello di rischio degli stessi, seguendo le GMP e le linee guida interne. Gestisce le modifiche su impianti e macchine di stabilimento, creando un network con gli SME delle varie aree aziendali.
In questo ruolo TU…
* Operarai in sinergia con gli SME delle varie aree aziendali (Engineering, Technical, Operations, QA, EHS, ecc), gestirai e organizzerai le attivit? di convalida GMP relativamente a equipment, facilities, Computer Systems, strumentazione, utilities di stabilimento;
* Sarai un supporto per attivit? ingegneristiche e qualitative nell'ambito di Validation Life Cycle.
* Verificherai la documentazione associata al processo di convalida, in base alle corrette strategie definite all'interno dell'unit? in accordo con le GMP riferimento.
* Coordinerai, mediante utilizzo del sistema MERP, le attivit? necessarie a mantenere sotto controllo le modifiche a sistemi convalidati e l'introduzione di nuovi sistemi (Change Control) per i Reparti di pertinenza e per le Utilities di Stabilimento;
* Coordinerai e gestirai Deviazioni Qualitative riferite all'Area Engineering, mediante utilizzo del sistema Veeva
* Emetterai Technical Impact Assessment nell'ambito di Deviazioni di Plant Maintenance, mediante utilizzo del sistema MERP
Perch? te?
Qualifiche e competenze di base:
* Laurea in Ingegneria, Chimica, Biotecnologie, CTF o materie scientifiche oppure esperienza equivalente;
* Pregressa esperienza in ruolo analogo;
* Esperienza nel settore farmaceutico;
* Conoscenza delle GMP (Good Manufacturing Practices);
* Buona conoscenza della lingua inglese.
Qualifiche e competenze preferenziali:
* Conoscenza del Validation Life Cycle
* Esperienza in ruoli tecnici e tecnologici
* Conoscenza delle tecnologie farmaceutiche e dei sistemi produttivi e analisi in ambito farmaceutico
* Conoscenza del Sistema MERP;
Closing Date for Applications - Thursday, July 4th, 2024.
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
Why (COMPANY NAME)?
Uniting science, technology and talent to get ahead of disease together.
(COMPANY NAME) 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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
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 (COMPANY NAME) a place where people can thrive. We want (COMPANY NAME) to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
If you require an accommodation or other assistance to apply for a job at (COMPANY NAME), please contact the (COMPANY NAME) Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
(COMPANY NAME) 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
(COMPANY NAME) 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 (COMPANY NAME)'s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to (COMPANY NAME). The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and (COMPANY NAME). 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 (COMPANY NAME). (COMPANY NAME) 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, (COMPANY NAME) may be required to capture and report expenses (COMPANY NAME) 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 (COMPANY NAME)'s compliance to all federal and state US Transparency requirements. For more information, please visit (COMPANY NAME)'s Transparency Reporting For the Record site
