- Drives Quality Assurance, Compliance and Technical Support for External Quality contract laboratories (ECLs) within the Pharma R&D organization and Janssen Supply Chain, primarily in the Americas region (North America and Latin America).
- This position serves in teams or major cross-functional project initiatives at the Divisional and the J&J companywide level with regard to management of the external contract labs used globally.
- Supports the EQ-ECL function Leader in the selection, development and management of External Contract Labs globally.
- Responsible for the end-to-end Quality and Compliance oversight of external contract laboratories (ECLs) which will test our Janssen vaccines, for product release and stability purposes, during Emergency use application (EUA) or Commercial stages.
- Supports and implements the strategy for continuous improvement of the external contract lab management processes.
- Supports the Pharma consolidation plan of external contract labs within DPDS and JSC-QC labs including increased usage of preferred labs. Main Duties/Additional Duties/Sphere of authority
- Support or deputize for EQ-ECL Account Owners responsible for the Vaccines' quality oversight for day-to-day ECL activities, primarily deviation and CPA management.
- Manage all utilized systems to ensure deviations are closed in time for release and stability.
- Independently solve issues as well as solving issues with key stakeholders like Subject matter experts from Analytical development, Covid testing team ECL managers, or EQ Account owners for CMOs.
- Will partake in the Vaccine program Janssen Q&C initiatives at the ECLs.
- Apply cGMP regulations, FDA and international requirements to all aspects of the position.
- Ensure timely and proper reporting to partners and stakeholders.
- Position may require flexibility in working schedule on occasion, in order to provide cGMP assistance and quality oversight, namely during key batch testing/release activities.
- A minimum of a Bachelor's or equivalent University degree is required, with a focus in engineering, science or an equivalent technical discipline preferred
- A minimum of 4 years experience in Pharmaceutical, Medical Device or Biotech regulated environment (e.g.
- A minimum of 2 years of experience in Pharma Quality Control or Analytical Development laboratories or closely related experience
- Experience in Quality Assurance, Quality Control and/or Compliance.
- Ability to provide cGMP compliance support to ECLs
- Knowledgeable of FDA/EMA regulatory requirements applicable to biologics and/or pharmaceuticals' testing is required.
- Ability to independently manage work to meet project objectives and timelines
- Ability to work within cross functional teams with global composition
- Strong interpersonal and written/oral communication skills
- Experience in using Pharmaceutical QMS systems
- Auditing experience
- Ability to build and nurture strong, positive relationships with business leadership
- Proficient in English language (speak, read & write) What type of mark will you make? By joining Johnson&Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls.
-
Quality Assurance Specialist
1 settimana fa
Recordati Group Provincia di Latina, Lazio, Italia**Recordati, established in 1926, is an international pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT , with a total staff of more than 4,300, dedicated to the research, development, manufacturing and marketing of pharmaceuti ...
-
Quality Assurance Specialist
1 settimana fa
amaris Latina, ItaliaJob description · Would you like to start a new professional adventure as Quality Assurance Specialist in one of our opportunities in the Pharmaceutical world in Latina? · You will be part of a Top Employer certified company which supports its partner in the main structured and i ...
-
Quality Assurance Specialist
1 settimana fa
Adecco Italia Frosinone, ItaliaRicerchiamo per conto di Azienda Cliente sita in provincia di Frosinone e operante in ambito chimico farmaceutico un Quality Assurance Specialist. La risorsa selezionata, nell'ambito del Gruppo di Quality Assurance e di concerto con il QA Manager e attraverso l'interazione con la ...
-
Quality Assurance Specialist
4 giorni fa
Adecco Italia Anagni, ItaliaHai una laurea in ambito farmaceutico? Sei interessato a lavorare nell'area quality Assurance? Ti piacerebbe lavorare in un'azienda moderna e organizzata? · Responsabilità: · La risorsa è inserita nell'area Quality Assurance di un'azienda farmaceutica, coordina o supporta le ispe ...
-
Field Quality Assurance Specialist, Last Mile
1 settimana fa
Amazon Italia Transport Srl Cisterna di Latina, ItaliaDiploma di scuola superiore o equivalente (livello 3 secondo il Quadro europeo delle qualifiche [EQF]) · - Altamente competente in italiano parlato e scritto (Quadro comune europeo di riferimento C1) · - Esperienza nell'uso di un sistema di gestione dei trasporti e di prodotti MS ...
-
Sterility Assurance Advisory Specialist
1 settimana fa
Particle Measuring Systems Frascati, ItaliaDo you want to be part of a business that genuinely values entrepreneurialism, innovation and individual accountability? We focus on our customers and are proud of the difference our technology makes. We partner with some of the biggest manufacturing companies in the world and ou ...
-
Quality Assurance Validation Specialist
1 settimana fa
amaris Aprilia, ItaliaJob description · Would you like to start a new professional adventure as Quality Assurance Validation Specialist in one of our opportunities in the Pharmaceutical world in Rome? · You will be part of a Top Employer certified company which supports its partner in the main structu ...
-
Quality Assurance Specialist
6 giorni fa
Randstad Pomezia, Italia A tempo pienoRandstad Talent Selection è la divisione di Randstad Italia specializzata nella Ricerca&Selezione di profili qualificati e specializzati. · Per strutturata azienda farmaceutica sita in provincia di Roma, siamo alla ricerca di un Quality Assurance Specialist, che riporterà dirett ...
-
Quality Assurance
4 giorni fa
Mister Temp Latina, Italia**MisterTemp srl Agenzia per il Lavoro (Aut.Min. e Iscr. Albo Agenzie per il lavoro n° 00027 del 22/12/2020) **ricerca per** **importante realtà operante sul territorio del Lazio un profilo tecnico da inserire per il ruolo di: · Il tuo ruolo · **Quality Assurance** · Requisiti · ...
-
Import/export Specialist
5 giorni fa
BSP Pharmaceuticals Latina, Italia**Descrizione azienda**: · **Posizione**: · We are currently looking for a _Import/Export Specialist _that will mainly ensure: · - Manage on time and accurately the shipment planning by processing the request coming from the Project Manager, Technology Transfer and/or from the cu ...
-
QA Validation Specialist
1 settimana fa
BSP Pharmaceuticals Latina, Italia**Descrizione azienda**: · BSP Pharmaceuticals S.p. A is focused on the development and manufacturing of anticancer drugs with high potency and cytotoxitc characteristics for the Pharmaceuticals Industry. · BSP has been at the forefront in the fight agains cancer since 2006. · In ...
-
Janssen Italy
1 settimana fa
Johnson & Johnson Latina, ItaliaCaring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing creative ideas, products and services to advance the health and well-being of people. We touch the lives of over a bil ...
-
Quality Assurance
6 giorni fa
Adecco Italia Pomezia, ItaliaLa risorsa verrà impiegata nella funzione di Quality Assurance in un contesto produttivo di una realtà chimico-farmaceutica importante del territorio. Sarà inserita in un contesto strutturato, lavorando in un team consolidato che riporterà al Quality Manager. · Nel dettaglio si o ...
-
Validation Specialist Consultant
1 settimana fa
FORTIL Aprilia, Italia**FORTIL** è una società di engineering consulting creata da ingegneri con mentalità imprenditoriale. Il nostro modello, nato nel 2009, si basa non solo su eccellenza e precisione, ma anche su condizioni di condivisione in continua evoluzione. Il 100% delle azioni del gruppo appa ...
-
Sop & Documentation Specialist
5 giorni fa
Adecco Italia Frosinone, ItaliaSei in possesso di una laurea in ambito Pharma? Hai maturato anche un'esperienza di stage nel settore relativo alla Documentation? · Adecco Italia Spa per multinazionale farmaceutica in provincia di Frosinone (FR) sta ricercando un/una: SOP & DOCUMENTATION SPECIALIST. · La risors ...
-
Health, Safety
1 settimana fa
Recordati Group Aprilia, Italia**Recordati, established in 1926, is an international pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT , with a total staff of more than 4,300, dedicated to the research, development, manufacturing and marketing of pharmaceuti ...
-
Team Leader, Brr
1 ora fa
Thermo Fisher Scientific Ferentino, ItaliaThe resource will be part of a team with multifaceted strengths · The role will Supervises and coordinates the activities of the Quality Operations team responsible for deviation management, BRR and projects. · It is responsible for achieving the quality objectives. It independen ...
-
Equipment Validation Specialist Settore Farmaceutico
1 settimana fa
Direzione Lavoro Group Anagni, ItaliaDirezione Lavoro Group Spa (Aut. Min. 0001 del 21/01/19) ricerca per azienda cliente operante nel settore farmaceutico, una figura di Equipment Validation Specialist per la sede in provincia di Frosinone. La figura si occuperà in collaborazione con il Quality Assurance Manager e ...
-
QA Specialist
5 giorni fa
Adecco Italia Pomezia, ItaliaPer azienda chimico farmaceutica di Pomezia ricerchiamo · 1 QA specialist · Requisiti fondamentali: · - Laurea in Ingegneria Chimica, Scienze Farmaceutiche o discipline correlate · - Esperienza di circa 2-3 anni in ambito Quality Assurance · - Buona conoscenza della lingua ingles ...
-
Sop & Documentation Specialist
2 giorni fa
Adecco Italia Ferentino, ItaliaSei in possesso della laurea in ambito farmaceutico? hai esperienza nell'area Quality System di un'azienda farmaceutica? Stiamo selezionando per una grande azienda farmaceutica una risorsa che si occupi del corretto mantenimento della documentazione GMP di sito, attraverso l'emis ...
Senior Quality Assurance Specialist - LATINA, Italia - Johnson And Johnson
Descrizione
Johnson & Johnson,we believe health is everything.Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at Objectives and ResponsibilitiesClosely works together with other J&J sector leads for external contract labs, Internal JSC-QC Lab representatives, DPDS, Site Quality leads, Product Quality management, Global Quality Lab Systems, Global Procurement and other stakeholders .
And with our commitment to be the world's healthiest workforce you can strengthen your body as well as your mind.
When you work at Johnson&Johnson you can touch over a Billion of lives worldwide every day.And when you apply your talent to our collective purpose there's no end to the lasting impact we can make together.
And that changes everything.Diversity, Equity & Inclusion at Johnson&Johnson means that "YOU belong" For more than 130 years, diversity, equity & inclusion have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.
Our commitment to respect the dignity and diversity of all is embedded in our Credo.We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued, and every one of our people feels that they belong and can reach their potential.
No matter who they are.