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Job Search Results: Jobs 1 - 10 of 24  View Titles & Details  Page 1 of 3
 
Title   Company Name     Location   Date  
Clinical and Quality Assurance Manager 

  Trendlines Group    North Area, Misgav Industrial Park ( Near Carmiel)   27/7/2016 
Category: QA - Quality Control, Clinical Research  
Education:   Position type: Full Time  Experience: 5 years 
Area(s) of expertise desired: Clinical Research, Medical Device, Orthopedics, Quality Assurance, Start-Up  
Description:
Manages all clinical aspects of a clinical study, including:
•Assesses operational feasibility and recommends study execution plan; participates in site monitoring visits as appropriate.
Select countries and sites for trial participation; develops relationships with K.O.L and site staff; coordinates and assists in the planning of regulatory or ethics committee activities, as appropriate;
•Design clinical trial protocols;

•Prepares/reviews site study documents
•Manages clinical monitoring activities (including approval of visit report templates, monitoring plan, etc.)
•Ensures all clinical trials are executed in compliance with ICH/GCP guidelines/regulations and applicable SOPs:
Manages all aspects of quality assurance activities including:
•Ensure compliance with FDA and other regulatory affairs
•Develop, administer and maintain quality assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements
•Establish quality assurance and quality control inspection and testing procedures
 
Requirements:
•Minimum 5 years clinical trial management experience in a medical device company - Mandatory
•Advanced knowledge of Good Clinical Practices and current knowledge of FDA regulations for clinical trials is required;
•International clinical trial experience
•Minimum 2 years Quality Assurance experience in a medical device company - Mandatory
•Thorough knowledge of FDA Quality System requirements, ISO 13485:2003 (Quality System) requirements
•Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
•Experience working with subcontractors
•Excellent English - written and verbal
•Excellent communication and organizational skills, along with problem solving,

Travel- Travel abroad required per week, per month

Location: Misgav Industrial Park
 
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experienced QA/RA professional 

  Li-Med - Asaf Azulay    Tel Aviv Area, Petach-Tikva   14/6/2016 
Category: QA - Quality Control, Biotechnology, Life Sciences, Medical Equipment, Regulatory Affairs, òáøéú åàðâìéú áøîä âáåää îàåã (÷øéàä, ëúéáä åãéáåø)  
Education: Masters   Position type: Full Time  Experience: 3 years 
Area(s) of expertise desired: GMP, Quality Assurance, Radiology, Regulatory Affairs  
Description:
We work with clients in the Medical Device field to build and implement their quality management system, as well as prepare regulatory strategy plans and files.  
Requirements:
B.A. in Mechanical Engineering/ Quality Engineering/ Biotechnology/ Life Sciences
2 years of experience with medical device Quality and Regulatory requirements (ISO13485, GMP)
Experience in writing and submitting regulatory documents for the European and American regulatory bodies
Experience with CE regulatory requirements
Has participated at least once in a CE quality/regulatory audit
Languages: proficient in Hebrew and English (reading, writing and speaking)  
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Computerized systems validation engineer 

  Comply    All   1/4/2015 
Category: QA - Quality Control, IT/Hardware/Software  
Education: Bachelors   Position type: Full Time  Experience: No experiece 
Area(s) of expertise desired: Business Analyst, Compliance, GLP, GMP, Information Systems, Medical Device, Other, Professional Services, Validation  
Description:
•Write Computerized systems validation documents and test protocols: STP,STD,IQ,OQ,PQ
•Write Computerized systems design and summary documents: URS,FRS,VP,STR,VSR
•Write SOPs ( Standard Operating Procedures) , Work instructions
•Write software applications reject lists, bug identification, report and monitoring.
•Functional testing of life-science computerized systems.
 
Requirements:
Minimum Qualifications

•Education: BA/BSC in Biotechnology, Chemical Engineering, Biomedical engineering, Chemistry, Biology, Computer Science
•Communication: Excellent oral and exceptional technical writing skills with the ability to interface effectively and professionally at all levels.
•Organized person with high ability to work with fine details.
•Excellent English( Equal to mother tongue).
•QA oriented : Experience with QA in the life-science industry( Pharma ,Biotech and Medical devices). Optional- Experience with QC in the life science industry.
•Service oriented.

Preferred Qualifications

•Experience with use of life science computerized system ( e.g. LIMS, ERP systems, computerized Lab systems ( Empower, FTIR etc..), production systems etc.)
•Experience with IT subjects (i.e. Server- Client topology, Data backups, Help Desk etc.)
•Experience in software testing\ computerized system validation in the life science industry
•Knowledge in roles and guidelines: 21CFRPart11, GAMP5 ISO 14971:2007,IEC 62304
 
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Account Executive Scientist 

  Michael Page    Tel Aviv Area   13/8/2013 
Category: QA - Quality Control  
Education:   Position type: Full Time Executive  Experience:  
Area(s) of expertise desired: Medical Device  
Description:
We are looking for an Account Executive Scientist to devolop the Israeli market for an Internaitonal company.
Actively involved, through direct participation in office or field clients visits to understand client’s needs, provide technical scientific or regulatory solutions, provide regulatory or business presentations
Makes client visits, with a special emphasis on scientific and regulatory aspects to generate new sales, expand volume of testing, consulting or clinical from current and new clients and obtain marketing and competitive information.
Contribute to establish and Implement annual sales plans and assists in the development and achievement of sales goals through effective interaction with clients, Company Project Development Advisor (PDA), scientists, sales, agents and other technical staff worldwide.
Assists with major accounts management and development in Israel.
 
Requirements:
Scientific Degree: Veterinarian, Pharmacist, PhD, MD, Engineering
0-5 years experience related to the Medical Devices Industry, Manufacturing, Regulations or Testing
Biomaterials Science, Medical Devices evaluation principles and standards, Medical Devices regulations.
Substantial, professional communications skills and analytical capabilities.
Outstanding motivation skills required. Willingness to travel both in Israel and internationally. Hebrew & English language proficiency.

 
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manager 

  larry bee    All, chicago   15/3/2012 
Category: QA - Quality Control, IT/Hardware/Software  
Education: Masters   Position type: Full Time Manager  Experience: 6 years 
Area(s) of expertise desired: Academic  
Description:
A management consulting firm, we are focused exclusively on the metals industry. Our objectives are to identify opportunities for clients to reduce the cost of new metal, improve the value received for scrap, manage price risk exposure and strengthen administrative and financial controls.  
Requirements:
A management consulting firm, we are focused exclusively on the metals industry. Our objectives are to identify opportunities for clients to reduce the cost of new metal, improve the value received for scrap, manage price risk exposure and strengthen administrative and financial controls.  
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Director, Manufacturing 

  Scientific Search    Worldwide   14/3/2011 
Category: QA - Quality Control, Biotechnology, Engineering, Chemistry, Life Sciences, Clinical Research, Clerical/Administrative, Management/Executive, Medical Management, Pharmacy/Pharmacology, Medical Equipment, Regulatory Affairs, Healthcare, Sales/Marketing  
Education: Bachelors   Position type: Full Time Manager  Experience: 10+ years 
Area(s) of expertise desired: Bioanalytical Services, Biology, Manufacturing/Production  
Description:
Summary
This position is responsible for the technical oversight of biomanufacturing activities at contract manufacturing organizations associated with the production of critical raw materials, Drug Substance and Drug Product.
Responsibilities
• Execute on time and cost the Manufacturing Supply Forecasts through oversight of third party manufacturers based in Japan, Israel and the US : Act as Person in Plant during manufacturing campaigns
• Conduct technical audits of manufacturing operations to identify opportunities for Continuous Improvement at third party manufacturers
• Technical review of batch documents
• Trouble shoot manufacturing issues and support QA in Deviation and CAPA activities
• Support QA in the technical review of Change Requests
• Assist the Chief Technology Officer in the development of budgets
• Provide data to populate the KPI program for Manufacturing
• Other projects and assignments as required.
 
Requirements:
Requirements
• BS Degree, in either bioengineering or a biological science.
• Fifteen-plus years experience in manufacturing of biological products
• Five-plus years in the management of biopharmaceutical manufacturing operations.
• Excellent communication skills in Hebrew, both oral and written.
• Profound knowledge of GMP requirements associated in biomanufacturing in the US and Internationally.
• Knowledge of the engineering aspects of biopharmacecutical manufacturing plants
• Experience working with CMO's
• Goal oriented with a problem solving mindset
• Proficiency with computers and major software packages, e.g. Microsoft Excel, Outlook, Powerpoint, Project
• Excellent communication skills in English, both oral and written.
• Travel - 25%
 
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director 

  ERICPOSEY CO LTD    Worldwide, FLUSHING   7/1/2011 
Category: QA - Quality Control, Pharmacy/Pharmacology  
Education: Masters   Position type: Full Time  Experience: 1 year 
Area(s) of expertise desired: Academic, Finance  
Description:
Degree Evaluation · Interviews · Networking ... A less positive attribute of this job search method is that numerous ... However, the main reason why companies refrain from massively posting job details is that employers ... Community Internet Sites – Many Israeli cities/regions have dedicated  
Requirements:
Degree Evaluation · Interviews · Networking ... A less positive attribute of this job search method is that numerous ... However, the main reason why companies refrain from massively posting job details is that employers ... Community Internet Sites – Many Israeli cities/regions have dedicated  
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Junior Sales Representative Surgical 

  Covidien    Tel Aviv Area, Tel Aviv   27/12/2010 
Category: QA - Quality Control, Biotechnology, Engineering, Chemistry, Clinical Research, Clerical/Administrative, Management/Executive, Medical Management, Pharmacy/Pharmacology, Medical Equipment, Regulatory Affairs, Healthcare, Sales/Marketing  
Education: Bachelors   Position type: Full Time  Experience: 3 years 
Area(s) of expertise desired: Medical Affairs, Medical Device, Sales  
Description:


Position: Junior Sales Representative Surgical (3)
Location: Central Israel (Tel Aviv)

Covidien

It's a new era with nothing but promise. Today, Covidien is more than a leading provider of medical devices, supplies and pharmaceuticals. We’re a $10 billion company with over 40,000 employees who are passionate about helping doctors, nurses, and other medical industry professionals to as effective they can be.
A company with a true global mindset, Covidien has forged dynamic partnerships with medical professionals around the world. In our role as an integral collaborator, we help identify patient needs and translate them into proven procedures and products that improve and save lives.

As a Junior Sales Representative Surgical focused on our prestigious products, you will work closely with doctors, surgeons and specialist groups, selling into hospitals and a variety of practices across the centre of Israel and Central region - Jerusalem.
In return, we will provide you with world-class training, frequent development opportunities, rewarding benefits and the opportunity to work in a varied, challenging role with a large scope for demonstrating your independence, innovation and your talent for sales.

As a Junior Sales Representative your main responsibilities will involve:

• Selling a portfolio of world renewed Surgical products across your established customer base
• Increasing sales in line with agreed budgets
• Building on well established relationships, to become an expert advisor to healthcare professionals
• Being resilient, a strong negotiator and advocate for your products whilst identifying new opportunities in your market place
• Cooperating with Customer Service Department
• Participating in preparation and monitoring outcome of tender offers within the territory

 
Requirements:
As a Junior Sales Representative your skills and qualifications will ideally include:

• Comprehensive selling experience B2B business (preferably in medical environment)
• Previous sales experience or the desire to develop your sales ability
• Good command of English to business standard
• A full clean Driving License

What we will be looking for in you:

This role will suit a performance-driven young individual who enjoys working in a competitive environment and seizes the opportunity to get the awards that over-achievement brings. Ideally, you’ll have excellent presentation and negotiation skills and genuinely enjoy building long-term, trusting relationships with your customers.

Contact:

To apply follow the link:
http://www.tycohealthcarecareers.com/tycohcinternational/jobboard/NewCandidateExt.aspx?__JobID 9449

 
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VP/ Director RA / QA 

  Mengo    All   8/5/2009 
Category: QA - Quality Control, Biotechnology, Pharmacy/Pharmacology, Medical Equipment, Regulatory Affairs  
Education:   Position type: Full Time Executive  Experience:  
Area(s) of expertise desired: Medical Device, Pharmacology, Quality Assurance, Regulatory Affairs  
Description:
Responsibilities:

1. To establish, maintain and improve the quality system in accordance with 21CFR820, ISO9001 and ISO13485
2. To act as the management representative as defined in the quality system responsible for:
• ensuring that quality system requirements are effectively established and maintained; and
• reporting the performance of the quality system to senior management for review

3. To manage the following quality system processes to ensure compliance with the applicable regulations, standards and directives including:
Documentation control, auditing, training, management review, complaints, product quality acceptance, supplier control, change control and quality planning.

4. Assist with the preparation, filing, and negotiation of submissions to regulatory bodies to obtain market or clinical research approvals including ongoing trials and post-approval activities.
5. Review clinical trial documents including clinical protocols/reports, investigator brochures, nonclinical reports, CMC protocols/test methods;
6. Reviews labeling, promotional material, product changes and documentation for changes requiring government approval
7. Monitor changes to domestic and international regulations and standards and ensure compliance with those regulations and standards
 
Requirements:
Qualifications:

** More than 10 years experience in the Biopharmaceutical or Medical Device industries.
**At least 5 years management experience in Quality assurance and Regulation in Biopharmaceutical or Medical Device industries.
** Experience with Notified Bodies in Europe.
** Experience with quality requirements for clean rooms and sterilization

 
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Level II Source Inspection 

  Verify, Inc.    North Area, Haifa & Nazareth   5/1/2009 
Category: QA - Quality Control  
Education:   Position type: Temporary Employee  Experience:  
Area(s) of expertise desired: Quality Assurance, Quality Control  
Description:
Contract position in Haifa and Nazareth. 40 hours p/week on an on-going basis. Pay per hour depends on candidate's skills and qualifications. Please see further details below. Candidate will be contracted through Verify, Inc., but the position is for General Dynamics Ordnance and Tactical Systems. Please call Michelle Katz at 203 638 6325 or e-mail to mkatz@vscnet.com.

Primary Duties: MUST BE US CITIZEN
• Report on potential and actual process, product and schedule issues as they arise
• Assess production readiness of the subcontractor(s) from material receipts through final USG approvals (Lot Acceptance Tests-(LAT), Ammunition Data Card (ADT), and DD 250); this includes materials availability (line of balance information), human resources, training, work loading and equipment status
• Identify production risks and work with supplier(s) to develop risk mitigation plans (single point failures, automated systems, etc)
• Aid in processing of all paperwork necessary to support production (ADC, DD250s and Bills of Lading)

Quality:
• Provide source inspection/acceptance services for the first articles and lot acceptance tests at subcontractor facilities in accordance with the technical data package
• Witness, approve, prepare and submit Product Acceptance Documentation (Inspection Records and Supporting Certifications) per the training and direction received from GD-OTS Quality Assurance Personnel. The documentation is to be submitted through the Subcontract Administrator
• Monitor and recommend subcontractor improvements based on process audits, inspection results and delivery
• Participate in testing and failure analysis, as required
• Provide corrective action suggestions for process improvement at subcontractor facility based on performance and customer complaints
• Provide support for GD-OTS executed process audits
• Assist GD-OTS personnel with the review of Ammunition Data Cards (ADC) and Certificate of Conformance (C of C’s) prior to official submittal from subcontractor
• Support quality system audit with GD-OTS personnel, as directed

Primary Products:
• Links (connect the bullets to make an ammo belt for example when ammo is being fed into a machine gun, the bullets are connected by links)
• Ammunition


 
Requirements:
 
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