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We are looking for you, passionate, self-motivated, and creative member to join our team.
we develops chemical/electrochemical hybrid systems to demonstrate our novel hydrogen generation technology.
We are looking for a creative and open-minded lab technician to join our Labs operations.
The technician will be responsible for lab maintenance; execute tests based on protocol, procedure, test plan, or other test instructions and participate in hands-on work according to the company goals.
KEY RESPONSIBILITIES:
Perform in-house machinery tuning and maintenance.
Maintenance of laboratory inventory, equipment needs, and laboratory function.
Troubleshooting and creative solutions for lab or machine-related problems.
Execute tests based on protocol, reliable documentation, and report.
Responsible for lab maintenance and routine handling.

Job Overview:
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions:
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
Collaborate and liaise with study team members for project execution support as appropriate.
If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Job Overview:
Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.

Essential Functions:
Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines. Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required. Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan. Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required. Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements. Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team. Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan. Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required. Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents. Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable). Mentor and coach colleagues as required. Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information. May take a lead role in developing long standing relationships with preferred our customers. Deliver presentations/training to clients, colleagues and professional bodies, as required. May be involved in activities related to monthly study budget planning and reviews.

Job Overview:
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions:
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
Collaborate and liaise with study team members for project execution support as appropriate.
If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

n this role, the Engineering & Manufacturing Quality Manager leads Sr. Quality Engineers, Quality Engineers and personnel who provide quality oversight the Ops Quality platform, such as Engineering, process validations, production lines development and qualifications, material acceptance, Quality presence at production and manufacturing failure investigations while working within a multi-functional team environment for medical devices. The Quality Engineering & Manufacturing Manager leads personnel who review and approve projects, tasks and nonconformities, from product realization, design transfer, production process establishment and changes, production controls and manufacturing supervision and plays an active role to ensure that production processes meet all applicable quality standards, consistent with internal procedures and acceptance criteria, while meeting applicable regulatory requirements. The Quality Engineering & Manufacturing Manager will be a strong advocate for product and process quality at all stages. Additionally, this role leads Sr. Engineers responsible for the medical devices sterilization methods establishment, validation, control, and maintenance activities. Furthermore, the Quality Engineering & Manufacturing Manager leads personnel who are responsible for the production documentation (DHR) and finished product release to market by monitoring the manufacturing and release processes, including a verification that the sterilization and Endotoxin levels meet the applicable requirements.

The Quality Engineering & Manufacturing Manager will support continuance improvement of product, process and QMS and provide guidance and support to all duties associated with the auditing and documentation of compliance related items against GMP and ISO standards for West and its subcontractors. The Quality Engineering & Manufacturing Manager will also lead a team executing the QMS related transactions in relevant GMP systems (Master Control, SAP, Share Point) and other relevant quality functions as applicable including external and internal audit support.

In this role, the QA Engineer supports products development and provides quality oversight to the R&D activities while working within a multi-functional team environment for medical devices.

The QA Engineer will play an active role to ensure the design and development process meets quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and applicable regulatory requirements as well as being involved in QA activities.



Essential Duties and Responsibilities:



QA focal point for R&D projects in design and development processes.
Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards
Responsible for final approval of R&D documentation- reviewing and approving technical and DHF documentation.
Responsible for approval of product development DHF documentation (DDP, PRD, TMX, design verification & validation activities, dFMEA risk documents, test methods, protocols, reports, product design transfer)
Responsible for approval of product design changes
Finding solutions for queries within responsibility limits
Assist and provide guidance on any out of specification result, deviation, or excursion that may occur
QA representative in product development design reviews
Work cross-functionally with individuals and project or extended teams to provide guidance and ensure success of projects
Attend program meetings as required as part of extended program teams