דרושים בחברת "ווסט ישראל"

נמצאו 3 משרות
*המשרות באתר מיועדות לנשים וגברים כאחד
· Responsible over the maintenance of the quality system procedures by verifying their compliance to relevant regulatory requirements
· Responsible over supplier/ subcontractor approval
· Responsible over supplier/ subcontractor evaluation
· Responsible for customer questionnaires
· Responsible for preparations for periodical management reviews
· Participation in external audits (notified body and customers)
· Perform internal audits
· Perform supplier audits
· Maintenance of the risk management file
· Write and update quality system procedures
· Support activities related to quality system training
· Support other QA dept activities- second approval of batch release, CAPA/ Corrections, customer complaints, QA agreements, QA monthly report, KPIs.




· Responsible over the maintenance of the quality system procedures by verifying their compliance to relevant regulatory requirements
· Responsible over supplier/ subcontractor approval
· Responsible over supplier/ subcontractor evaluation
· Responsible for customer questionnaires
· Responsible for preparations for periodical management reviews
· Participation in external audits (notified body and customers)
· Perform internal audits
· Perform supplier audits
· Maintenance of the risk management file
· Write and update quality system procedures
· Support activities related to quality system training
· Support other QA dept activities- second approval of batch release, CAPA/ Corrections, customer complaints, QA agreements, QA monthly report, KPIs.




דרישות:
Basic Qualifications:
• Education: B.Sc. in Science or Engineering
· Experience:
o At least 4 years working in quality system at Medical Device/ Pharma. industry
o A qualified auditor
Preferred Knowledge, Skills and Abilities:
· Courses on topics related to quality system in the medical device/pharma industry

מיקום המשרה: מרכז, שרון
סוג משרה: משרה מלאה, משרה זמנית
תאריך עדכון: 03/05/2020
קוד משרה: JB-00095
אנו חברת מיכשור רפואי בינלאומית מרעננה, המגייסת הנדסאי/ת או טכנאי/ת להצטרף לצוות המעבדות שלנו!
אנו מפתחים ומייצרים מיכשור רפואי לערבוב והזרקה של תרופות לשיפור חיי מטופלים ומטופלות ברחבי העולם.
התפקיד כולל:
ביצועי בדיקות מעבדה מכאניות וניסויים, ביצוע שיטות בדיקה והפעלת ציוד במעבדה.
השתתפות במשימות המעבדה- הרכבות, בדיקות כוח, הכנת תמיסות ובדיקות ויזואליות.
העבודה מרובת ממשקים מול מחלקות שונות בארגון (פיתוח, QC והנדסה).
אנו חברת מיכשור רפואי בינלאומית מרעננה, המגייסת הנדסאי/ת או טכנאי/ת להצטרף לצוות המעבדות שלנו!
אנו מפתחים ומייצרים מיכשור רפואי לערבוב והזרקה של תרופות לשיפור חיי מטופלים ומטופלות ברחבי העולם.
התפקיד כולל:
ביצועי בדיקות מעבדה מכאניות וניסויים, ביצוע שיטות בדיקה והפעלת ציוד במעבדה.
השתתפות במשימות המעבדה- הרכבות, בדיקות כוח, הכנת תמיסות ובדיקות ויזואליות.
העבודה מרובת ממשקים מול מחלקות שונות בארגון (פיתוח, QC והנדסה).
דרישות:
תעודת הנדסאי/ת מכונות/ביוטכנולוגיה/כימיה או טכנאי/ת מכשור רפואי- יתרון משמעותי.
אנגלית ברמה גבוה- חובה!
ניסיון דומה ממעבדה/חברת מכשור רפואי- יתרון משמעותי.
מיקום המשרה: מרכז, שרון
סוג משרה: משרה מלאה
תאריך עדכון: 18/02/2020
קוד משרה: JB-00080
· Complete regulatory assignments with guidance in support of R&D and commercial programs with a focus on creating packaging and labeling artwork for labeling medical products and for submission to Health Authorities.
· Ensure that labeling, art including promotional materials meet all medical, legal and regulatory requirements in compliance with regulations, guidelines and procedures.
· Develops editor's copies and review artwork ensuring that all components meet the appropriate labeling requirements and guidelines. Gathers and evaluates all relevant information to support labeling changes for each project and maintains detailed audit trail.
· Under general supervision, participates in global labeling projects to completion, working closely with Regulatory, Quality, R&D and Clinical personnel for the design and to ensure accuracy of all labeling as well as timeliness of projects so that all commitments and deadlines are met.
· Facilitates the review and approval processes for new and post market change artwork and labeling from development through final proofs, including translations.
· Maintain working knowledge of computer software packages including CAD, MS Word, MS Excel, MS PowerPoint, Adobe, SharePoint and others as required.
· Complete regulatory assignments with guidance in support of R&D and commercial programs with a focus on creating packaging and labeling artwork for labeling medical products and for submission to Health Authorities.
· Ensure that labeling, art including promotional materials meet all medical, legal and regulatory requirements in compliance with regulations, guidelines and procedures.
· Develops editor's copies and review artwork ensuring that all components meet the appropriate labeling requirements and guidelines. Gathers and evaluates all relevant information to support labeling changes for each project and maintains detailed audit trail.
· Under general supervision, participates in global labeling projects to completion, working closely with Regulatory, Quality, R&D and Clinical personnel for the design and to ensure accuracy of all labeling as well as timeliness of projects so that all commitments and deadlines are met.
· Facilitates the review and approval processes for new and post market change artwork and labeling from development through final proofs, including translations.
· Maintain working knowledge of computer software packages including CAD, MS Word, MS Excel, MS PowerPoint, Adobe, SharePoint and others as required.
דרישות:
· Bachelor's degree in an appropriate discipline, preferably with strong science background. Strong command of the English language required to be able to produce print-ready material.
· Must have 2 years minimum experience in the pharmaceutical/medical device industry, with specific
product labeling experience and/or demonstrated ability to process labeling within the skills defined


Preferred Knowledge, Skills and Abilities:
Graphics/ printing related experience in the pharmaceutical/medical device industry:
· Working knowledge of graphic design software applications such as CAD, with more advanced knowledge of Adobe Illustrator and Adobe Acrobat.
· Knowledge of ISO 15223: 2016
· Solution-driven attitude, ability to autonomously develop a course of action leading to a beneficial
outcome.
· Ability to effectively operate in a multicultural environment which requires negotiation,
collaboration and adaptation.
· Ability to work with minimum/general supervision and escalate relevant information to
management.
· Well-developed interpersonal and leadership skills.
· Strong organizational skills with demonstrated ability to effectively manage several projects in parallel.

מיקום המשרה: מרכז, שרון
סוג משרה: משרה מלאה
תאריך עדכון: 22/01/2020
קוד משרה: JB-00099