Lavori attuali relativi a Sr. Specialist, External Quality - Rome - MSD France
-
Sr Specialist Supplier Quality
3 mesi fa
Rome, Italia Baxter A tempo pienoThis is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...
-
Global Brand Content Sr. Specialist
3 mesi fa
Rome, Italia Amplifon A tempo pienoWho we areAmplifon is the global leader in the retail hearing care industry. Over 20,000 professionals in 26 countries, coming from more than 100 different nationalities, work every day in a global network of 9,500 points of sales to empower thousands of people to rediscover all the emotions of sound. In Amplifon we believe people are the most important...
-
Quality assurance specialist
2 mesi fa
Metropolitan City of Rome Capital, Italia Manpower ON SITE LOMB OCC A tempo pienoAzienda settore famaceuticoOfferta di Lavoro: Quality Assurance Specialist a Milano Descrizione del ClienteTipo di Cliente: Azienda leader nel settore farmaceuticoPosizione: MilanoSettore: FarmaceuticoCaratteristiche dell'Azienda: Innovativa, dinamica e in costante crescitaValori dell'Azienda: Qualità, Innovazione, ResponsabilitàDescrizione del...
-
Resource Specialist
3 mesi fa
Rome, Italia DLA Piper A tempo pienoThe Resource Specialist for DLA Piper’s Italian Flex offering sits within the International Flex team and plays an integral part in the delivery and embedding of our flexible legal service.Working closely with team members, you will be accountable for delivering a ‘best in class’ recruitment experience for candidates, as well as internal and external...
-
Sr. Solution Product Manager
3 mesi fa
Rome, Italia Supermicro A tempo pienoSupermicro is seeking a (Sr) Solution Product Manager who can help sales to grow business in different vertical market in EMEA, set up eco-system with different suppliers, grow company business with different sales team together, and directly engage with customers and provide solutions to end-users. As a (Sr) Solution Product Manager, you will use...
-
IT Quality
5 mesi fa
Rome, Italia Moncler A tempo pienoFor our IT Integrated Supply Chain Team we are looking for a new resource to join the SAP Quality control & SAP Manufacturing Solution area to be based at our HQ in Milan or Trebaseleghe (PD).Your impactThe person will play a pivotal role in advancing our quality management processes within the SAP ecosystem, overseeing the development and implementation of...
-
Sr. Solution Product Manager
2 giorni fa
Rome, Italia Supermicro A tempo pienoSr. Solution Product Manager Date: Aug 23, 2024 Location: Italy - Rome Company: Super Micro Computer Job Req ID: 23015 About Supermicro: Supermicro is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop/ Big Data, Hyperscale, HPC and...
-
PR Specialist
4 settimane fa
Rome, Italia Netflix A tempo pienoNetflix is one of the world’s leading entertainment services with 278 million paid memberships in over 190 countries enjoying TV series, films and games across a wide variety of genres and languages. Members can play, pause and resume watching as much as they want, anytime, anywhere, and can change their plans at any time. The Role PR Specialist -...
-
Quality Assurance Specialist
1 mese fa
Rome, Italia Manpower A tempo pienoDescrizioneManpowerGroup ricerca per azienda che sviluppa e produce in tutto il mondo API (principi attivi), in provincia di Milano, un/una QA Specialist. Requisiti:- Possibilmente Laurea in Chimica, Chimica Industriale, CTF o simili; - esperienza di almeno 5 anni in aziende farmaceutiche e dimestichezza con le norme contenute in The Rules Governing...
-
Sr Director
2 settimane fa
Rome, Italia InvenSense A tempo pienoFounded in 2003, InvenSense Inc., a TDK Group Company, is the world’s leading provider of MEMS sensor platforms. InvenSense’s vision of Sensing Everything targets the consumer electronics and industrial markets with integrated Motion and Sound solutions. Our solutions combine MEMS (micro electrical mechanical systems) sensors, such as accelerometers,...
-
Junior Quality Engineer
2 mesi fa
Rome, Italia RINA A tempo pienoRINA is currently recruiting for a Junior Quality Engineer to join its office in Rome within the Aerospace & Defence Division. Mission This role focuses on providing support to engineers in designing solutions, products, machines, systems or structures, respecting time, budget, and quality requirements. Key Accountabilities Support...
-
Quality Control Specialist
5 giorni fa
Metropolitan City of Rome Capital, Italia Randstad Inhouse - Roma A tempo pienoJob OverviewRandstad Inhouse Services is actively seeking a Quality Control Engineer for a prominent aerospace client.Quality Control plays a vital role in the aerospace sector, ensuring the precise execution of Assembly Integration and Test activities for Payload, Observation, and Navigation Satellites, in alignment with company protocols and specific...
-
Documentation Specialist
3 mesi fa
Rome, Italia SIX Payment Services A tempo pienoDocumentation Specialist Date posted 12/21/ Location Cernusco sul Naviglio | Italy, Marano di Napoli | Italy, | Italy, Milan | Italy, Rome | Italy Company Worldline Our daily task in the Data Magagement team is to develop reports in various formats for external and internal stakeholders in card-based payment transactions, to expand the interfaces and to...
-
Sulphur Technology Process Specialist
5 mesi fa
Rome, Italia KT - Kinetics Technology A tempo pienoShe/he will act as a subject matter expert to provideknowledge and expertise in sulphur and amine related technologies and businessareas such as: Sulphur Recovery Unit, Tail Gas Treatment Unit, Tail Gas Thermaland Catalytic Incineration, Amine Treating Unit, Acid Gas Enrichment, Acid GasRemoval, Sour Water Stripping, Flue Gas Cleaning (DeSOx, DeNOx etc.). ...
-
Procurement Sustainability Specialist
2 mesi fa
Rome, Italia Bridgestone A tempo pienoJob Description Summary: The EMIA procurement vision and corporate E8 initiative establishes the procurement organization as a pivotal part of Bridgestone’s path towards sustainability (“EMIA procurement is your strategic partner in BSEMIA bridging the sourcing of sustainable solutions, compliance new industry certification standards and...
-
Technical Specialist Automation
1 mese fa
Rome, Italia Abbott A tempo pienoAbout Abbott Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160...
-
Technical Specialist Automation
2 mesi fa
Rome, Italia Abbott Laboratories A tempo pienoAbout AbbottAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160...
-
Biddable Specialist
2 settimane fa
Rome, Italia Zenith A tempo pienoCompany DescriptionAbout ZENITHWe are the connected marketing agency, a full-service agency with modern creative & media, data, and technology services all under one roof.We are connected in the way we think and the way we work. At the heart of our company are great people that we call Unicorns. Our Unicorns are open, bold, and curious and love to solve...
-
Meeting Specialist
4 mesi fa
Rome, Italia FAO A tempo pienoIMPORTANT NOTICE: Please note that Closure Date and Time displayed above are based on date and time settings of your personal device FAO is committed to achieving workforce diversity in terms of gender, nationality, background and culture. Qualified female applicants, qualified nationals of non-and under-represented Members and person with disabilities...
-
Team Leader, QA
4 settimane fa
Rome, Italia ThermoFisher A tempo pienoWork ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionSCOPO DELLA POSIZIONE/RESPONSABILITÀ:Alle dipendenze del QOPS Supervisor di riferimento e del QOPS Supervisor, supporta la Persona Qualificata nel giudizio sui lotti prodotti e sull’ambiente di lavorazione, attraverso la verifica della documentazione e delle altre informazioni...
![MSD France](https://media.trabajo.org/img/noimg.jpg)
Sr. Specialist, External Quality
1 mese fa
An amazing opportunity has arisen for an External Quality Senior Specialist. You will be accountable for ensuring that all products are manufactured, packaged, tested, released, stored, and distributed in accordance with company expectations and all applicable regulatory requirements. You may also be accountable for ensuring all activities at the External Entity (EE) site associated with the manufacturing of company products, which includes quality oversight over manufacturing, testing, packaging, storage, and distribution of the products manufactured at an EE and to assure they have been produced or tested following approved processes/ methods in conformance to all applicable regulatory requirements, regulatory filings and company policies.
Ability to travel up to 25%, occasionally on short notice.
This role will be to support EU-based External Partner, as such remote working considered.
Responsibilities include, but are note limited to:
Bring energy, knowledge, innovation and leadership to carry out the following:
- Being responsible for implementing Quality Control policy, supporting the compliant supply of product by external manufacturers of sterile pharmaceuticals / biologics / vaccines, by means of a risk based quality oversight, support and technical advice, counselling of manufacturing site senior leadership and providing on-site supervision as appropriate;
- Reviewing the executed batch records and ensure that the product has been produced in compliance with the approved batch record instructions;
- Evaluating and/or releasing products with the assurance that the goods were manufactured in conformance to all applicable policies/procedures and compliance with all governing regulations; reviewing and approving changes to master batch records or laboratory methods/specifications;
- Taking responsibility for oversight of an External Entity (EE), involving releasing of products for further processing, with the assurance that the goods were produced or tested in conformance to all applicable policies and procedures and compliance with all governing regulations;
- Providing Quality Control oversight for method validations/method transfers and method improvements at external parties;
- Following up and ensuring timely close out of all corrections associated with the Batch Record Review;
- Participating in routine weekly Tier 2 meetings / teleconferences between ExM and Contract Manufacturing Operations (CMOs);
- Co-ordinating the full investigation into all Customer Complaints received for any of the batches manufactured by the CMOs;
- Assuring CMO compliance with established policies / procedures of the Division and Corporate and compling with all applicable governmental Regulations (GMP, FDA, etc.);
- Being responsible for on-going execution of the Quality Agreement with the External Party;
- Contributing to EQA Management Operational and Strategic Initiatives;
- Operating in a safe and efficient manner and in compliance with the Safety and Health Policy;
- Promote and participate in the implementation and maintenance of the SHE / EHS programmes relevant to you
- Participating in risk assessments, inspections, audits, incident investigations, etc., and implementing and following-up CAPA’s assigned to them;
- Providing Quality Oversight to the preparation of the Annual Product Review Report for the products associated with the CMO;
- Being accountable for ensuring metrics are compiled, analyzed, and reported, including identification of trends and/or root cause(s), to help develop new initiatives and process improvements;
- Assisting in the co-ordination of significant investigations, including Fact Findings. Assisting in the co-ordination of any product recall involving the external manufacturer.
Qualifications
Education and Minimum Requirements:
- Degree in Science, Engineering or other relevant technical discipline (e.g. BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred);
- Minimum of 3 years relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
Required Experience and Skills:
- Must have strong stakeholder management, communication, coaching,
motivation, negotiation, and persuasion skills to build strong relationships; - Ability to work across boundaries;
- Demonstrated interpersonal, relationship building, and leadership skills;
- Good English level, both verbally and in writing;
- Eligibility as Qualified Person it's preferred.
Current Employees apply
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
RemoteShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
08/17/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date:08/17/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R302017