The Quality Assurance Specialist oversees Data Integrity, compliance initiatives, validates documentation, and collaborates on improvement projects within the pharmaceutical sector.
Scopo del ruolo
Il Quality Assurance Specialist riportando al Quality Assurance Manager all'interno dell'organizzazione QO, è' responsabile della revisione e dell'approvazione della documentazione di convalida di equipment, utilities, facilities , processi , computer systems. E' il contatto diretto per gli aspetti di Data Integrity. Partecipa attivamente ai programmi di compliance e alle iniziative di miglioramento continuo dello stabilimento.
Responsabilità Principali:
Requisiti
Altri requisiti
Work Location Assignment: On Premise
Si offre contratto a tempo determinato di 11 mesi.
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let's start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
Quality Assurance and Control
Il Quality Assurance Specialist riportando al Quality Assurance Manager all'interno dell'organizzazione QO, è' responsabile della revisione e dell'approvazione della documentazione di convalida di equipment, utilities, facilities , processi , computer systems. E' il contatto diretto per gli aspetti di Data Integrity. Partecipa attivamente ai programmi di compliance e alle iniziative di miglioramento continuo dello stabilimento.
Responsabilità Principali:
- E' il contatto diretto dello stabilimento per aspetti di Data integrity, di Qualità e Compliance.
- Partecipa ai meeting di Data Integrity del team Global, e sviluppa e guida programmi di compliance in accordo alle strategie del Global, informa il management di eventi o programmi relativi alla Data Integrity Global.
- Garantisce la definizione dei piani di convalida e fornisce, quando appropriato, supporto per l'esecuzione delle attività stesse. Approva la documentazione di convalida (protocolli, rapporti, ecc.).
- Garantisce l'esecuzione delle attività di Data Integrity previste nel proprio ambito
- Collabora con il QA manager in caso di non conformità rilevate per la relativa gestione.
- Opera attraverso i sistemi informatici aziendali (es. LIMS/SAP/EBR/EDES/PDOCS/e-QMS/QTS)
- Emette rivede e approva la relativa documentazione nel rispettando dei principi ALCOA
- Collabora alle ispezioni interne ed esterne
- Redige procedure operative che garantiscano la conformità agli standard e alle linee guida interne ed esterne
- Partecipa ai progetti e iniziative di miglioramento continuo di stabilimento
Requisiti
- Laurea in discipline tecnico scientifiche (Laurea in CTF, Farmacia, Chimica, Biologia, Ingegneria) o esperienza equivalente almeno 5 anni nel settore Farmaceutico con responsabilità di Data Integrity e Alarm Management
- Inglese fluente scritto e parlato
Altri requisiti
- Avanzata conoscenze dei requisiti di Data Integrity (CFR21 part 11, ALCOA principles etc) e delle GMP.
- Utilizzo di AI, sviluppo di dashboard con power BI o analoghi.
Work Location Assignment: On Premise
Si offre contratto a tempo determinato di 11 mesi.
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let's start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
Quality Assurance and Control
Top Skills
AI
E-Qms
Ebr
Edes
Lims
Pdocs
Power BI
Qts
SAP
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