49 jobs voor investigator gevonden

What will you do?

• Lead production investigations: Conduct thorough investigations within our production process according to GMP standards to ensure safe product releases.
• Primary contact for regulatory agencies: Act as the main point of contact during inspections and defend investigation strategies.
• Drive continuous improvement: Implement process improvements and lead challenging trend investigations to reduce recurring deviations.
• Build strong partnerships: Collaborate with various stakeholders to ensure efficient execution of validation and production schedules.

Start kwaliteitsonderzoeken na melding van de operationele afdeling.Beheer en onderzoek meerdere kwaliteitsincidenten tegelijkertijd.

Documentation and reporting the investigation results to PAN E NW Strategy Management..Sharing the Strategies & Standards with Affiliates and support them.. Supporting Network Teams about Strategies & Standards:..

Responsibilities:

• Collaborate with on-site staff to provide guidance and solutions for production issues.
• Manage and review production investigations, CAPA's, change control, and complaints.
• Analyze quality indicator data.
• Work with different departments to solve issues and gather necessary information.
• Manage projects and follow safety, quality, and c.GMP requirements.
• Lead continuous improvement efforts and assist colleagues with quality concerns.
• Perform risk assessments and consult management for complex decisions.

Analyse et traitement de façon proactive et qualitative toutes les demandes du Client/de la première ligne/du sales (investigations, commandes.), par sa maîtrise des procédures internes..Consolider la relation de confiance avec le client et le fidéliser..

.Vous assurez les dépannages et les investigations techniques suite aux pannes.Vous assurez les activités de maintenance et de calibration selon le planning établi.Vous assurez les rondes techniques et la supervision des installations.

Wat ga je doen?

• Productieonderzoeken leiden: Je voert grondige onderzoeken uit binnen ons productieproces volgens GMP-standaarden om veilige productreleases te garanderen.
• Contactpersoon voor regelgevende instanties: Je bent het aanspreekpunt tijdens inspecties en verdedigt onderzoeksstrategieën.
• Continue verbetering stimuleren: Je implementeert procesverbeteringen en leidt uitdagende trendonderzoeken om herhalende afwijkingen te verminderen.
• Sterke samenwerkingen opbouwen: Je werkt samen met diverse stakeholders om een efficiënte uitvoering van validatie- en productieschema’s te waarborgen.



Investigation of Technology/Design/Product  Documentation and reporting the investigation results to PAN E NW Strategy Management.Developing PAN E Network Strategies & Standards  Documentation and reporting the developed Strategies & Standards to PAN E NW Strategy Management.

• Perform quality tests for CAR-T cell therapy production within a controlled c.GMP cleanroom environment.
• Ensure that all tests are carried out according to applicable procedures, standards, and GMP regulations.
• Conduct analytical tests on raw materials, in-process samples, and final product samples.
• Document test results in electronic systems like LIMS.
• Draft, review, and approve relevant QC documents, SOPs, and work instructions.
• Manage daily production planning and support production investigations.
• Create and review SOPs, work instructions, master batch records, and forms.
• Ensure compliance with safety policies, quality systems, and c.GMP requirements.

Je bent verantwoordelijk voor de kwaliteitscontrole van productie, beoordeelt en beheert productieonderzoeken, CAPA's, Root cause analyses en klachten, en voert risicobeoordelingen uit.Kwaliteit en compliance: Je zorgt ervoor dat alle onderzoeken voldoen aan de hoogste GMP standaarden en regelgeving als beoordeelt SOP's, werkvoorschriften, master batch records en andere documenten..Je leidt onderzoeken naar afwijkingen en ondersteunt andere afdelingen hierbij.

One of your main tasks will be to investigate complaints, deviations, out-of-specifications (OOS) and non-conformities, draft a report on these and propose corrective and preventive actions (CAPA).

You will take on a part of the batch release activities of the medicines and other medical products produced on site.Additionally, you will monitor compliance to the internal Standard Operating Procedures (SOPs) and GMP (flows and zoning included) in production and the laboratory.

More specific:

• Investigation and drafting of report for deviations; OOS; complaints and non-conformities.Monitor compliance on internal standard operating procedures (SOP’s) and GMP in production and laboratory area
• Final batch release - including review of batch records (1-2h per day)
• GMP/GDP/Pharmacovigilance training of QC and production operators; warehouse workers and drivers.
• Writing of the yearly PQR (Product Quality Review)
• Review of QC and GMP procedures
• Involvement in GMP validation and qualification activities (equipment and processes in production and laboratory area) and other GMP projects
• Management of CAPA’s related to GMP activities
• Management of change controls related to GMP activities
• Support during (preparation of) audits on site
• Perform internal audits at other sites and suppliers

Je bent verantwoordelijk voor de kwaliteitscontrole van productie, beoordeelt en beheert productieonderzoeken, CAPA's, Root cause analyses en klachten, en voert risicobeoordelingen uit.Kwaliteit en compliance: Je zorgt ervoor dat alle onderzoeken voldoen aan de hoogste GMP standaarden en regelgeving als beoordeelt SOP's, werkvoorschriften, master batch records en andere documenten..Je leidt onderzoeken naar afwijkingen en ondersteunt andere afdelingen hierbij.

Navigate through various online platforms, including MES, SAP, COMET and e.LIMS Initiate product non conformance investigations and deviation investigations in COMET as necessary.

Emphasizing innovation and customer centricity, it leverages advanced technologies to deliver tailored solutions that meet the evolving needs of its stakeholders...

For a major medical company specialised in clinical research we are looking for a Logistics Coordinator.You’ll be arranging all supply chain and transportation administration on all researched and yet to be researched samples.

Identifies and investigates anomalies, issues or variance to be addressedProject management * Initiates, analyses and works on projects which deliver business solutions through improved processes which can include improved efficiencies, delivering additional customer services or leveraging outsourcing or vendor opportunities within department.Kpi et reporting* Validates or completes accurate and timely reporting.Compiles data from all relevant sources, including externally as appropriate.

Cooperate with different stakeholders in defining the expected process maturity.Accompany process (maturity) investigations/ triggered by audits/risk functions/regulators.

Modify, review, and ensure contractor quality standards and protocols for processing materials into partially finished or finished products meet company and GMP requirements..Contribute to the completion of milestones associated with specific projects..

Review and draft a variety of legal documents including contracts, agreements, and other relevant materials..Assist with internal investigations, audits, and risk assessments related to compliance matters..

Genk..Jij als studiecoördinator (Future Health).

Surveillance des bancs d’essais et de leurs paramètres.Préparation et investigation des specimens d’essai.

Développer des programmes de mesure complets et former les opérateurs à mesurer pendant la production.Établir des standards pour l'utilisation des MMT, des scans 3D et d'autres techniques de mesure.

You execute development tasks:.You collaborate with the engineering teams of EDF Renewables and/or other partners for the technical design of the project and collecting government investigations and studies for site characterization (including but not limited to permit and environmental conditions, geotechnical studies, wind measurements, and metocean studies) You facilitate citizen participation You ensure that major development risks of the project are controlled You manage development aspects of the project on a day to day basis You participate in the choice of technologies and aspects of procurement procedures related to the project, industrial plan, contracting strategy, and layout You develope the project with a competitive business case in mind, consistent with the needs of the shareholders and market standards. .

Reporting to the Chief Medical Officer (CMO), the Medical Director (MD) will lead clinical development activities for new drug candidatesacross multiple therapeutic areas and indications.The MD will assume a hands-on role in the design and oversight of clinical trials, in close partnership Clinical Strategy and Operations, Regulatory Affairs, Pharmacovigilance, and Clinical Research Organizations (CROs).

This includes expert level troubleshooting and root cause investigation, mapping out in house training, providing input on product launches.You will identify, deliver, and assess future and current training needs for the field service teams, provide troubleshooting assistance to Technical Support Specialists and use your expertise to drive to resolution.You will become a dynamic ambassador for the Hologic brand, representing our innovative spirit and commitment to excellence. KEY RESPONSIBILITIES Gather feedback, improve resolution time to deliver effortless customer experience Conduct and provide workflow expertise for improving current customer's solutions Bridge regional intelligence to headquarters, clinical application team and internal and external partners Conduct in house trainings for field service teams (direct and indirect markets) and other relevant internal teams to assist in furthering knowledge of Hologic product solutions according to Hologic Global Standards – virtual & F2F Build and leverage strong relationships with all internal departments to achieve objectives

This includes expert level troubleshooting and root cause investigation, mapping out in house training, providing input on product launches.You will identify, deliver, and assess future and current training needs for the field service teams, provide troubleshooting assistance to Technical Support Specialists and use your expertise to drive to resolution.You will become a dynamic ambassador for the Hologic brand, representing our innovative spirit and commitment to excellence. KEY RESPONSIBILITIES Gather feedback, improve resolution time to deliver effortless customer experience Conduct and provide workflow expertise for improving current customer's solutions Bridge regional intelligence to headquarters, clinical application team and internal and external partners Conduct in house trainings for field service teams (direct and indirect markets) and other relevant internal teams to assist in furthering knowledge of Hologic product solutions according to Hologic Global Standards – virtual & F2F Build and leverage strong relationships with all internal departments to achieve objectives

A Functional Analyst, like a Business Analyst, connects the business with IT.The difference is that a Functional Analyst specialises in a specific subject matter: a technology, a line of business, a domain or industry.As a Functional Analyst, you are fully aware of all the attributes, characteristics and functions of your field.You can rely on your expertise to define the feasibility of a solution, its implementation, and its interaction with existing systems. 

Your responsibilities include:  

• Analysing and defining the needs and/or problems of the end users 
• Converting business needs into detailed and clear functional design documentation 
• Supporting the programming and/or implementation of the application 
• Functional testing of the application 
• Giving functional advice 

• Training of business end users

   

Manage relationships with airport authorities and government agencies..Provide expert input on operational initiatives and improvement programs..