דרושים Quality Control Associate

In this role, you will be responsible to handle raw materials acceptance activities, NCM reports related to raw materials, write and update procedures and forms related to incoming inspection.

• Responsible for raw materials acceptance activities in ERP/SAP, including approval of acceptance records generated by incoming inspectors and issuance of Certificate of Compliance for approved raw material.
• Responsible to verify that all acceptance test results follow GMP and GDP guidelines
• Responsible for handling of all related incoming inspection non-conforming materials (NCM), including performing root cause analysis, generate corrective actions and leading MRB meetings to determine the materials disposition.
• Responsible to write Special inspection /Rework instruction related to incoming inspection process
• Responsible to write and update incoming inspection Forms and procedures
• Responsible for the approval of all graphic and label related raw material.
• Responsible for the approval of Line clearance performed by quality inspectors

• Education- Technical/ Practical Eng.
• At least 2 years of relevant experience in Quality in the Medical Device/pharma industry
• Courses related to Medical Device regulation- an advantage
• Knowledge with ERP/ SAP- an advantage

• At least 2 years of relevant experience in Quality in the Medical Device/pharma industry

• Ability to work under pressure
• Good interrelation skills
• Technical ability- ability to read technical drawings
• Creativity
• High Learning ability
• Organized
• Ability to prioritize
• Excel -basic knowledge and experience.
• Written and verbal communication skills: Hebrew- Mother tongue . English- Good

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events
• Must maintain the ability to work well with others in a variety of situations
• Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception and the ability to adjust focus.
• Ability to perform basic mathematical tasks like counting, adding, subtracting, and rounding and to record, balance and check for accuracy.
• Effectively communicate and interface with various levels internally and with customers

Additionally, this role will identify and implement improvements to the production processes.

The Manufacturing Quality Engineer will be the products and production focal point for our sub-contractors and will be responsible for projects related to the production and machines, including training, audits, stop and renew the production.

• Exhibit a strong “quality first” mentality and ensure that product and quality are held to the highest standard.
• Meet company and departmental goals in the continuous improvement of all products, services and processes.
• Work cross-functionally with individuals or extended teams to provide guidance and ensure success of projects
• Responsible to write, review and approve pilot documents (including reports).
• write and approve various department and production procedures and forms.
• Lead investigation processes for deviations and nonconformities in production and create analysis reports.
• Responsible to train the sub-contractors according QA procedures and VoE.
• Supports special processes such as sorting or rework in production.
• Own on all production activities at one of the subcontractors to ensure manufacturing is held according to West procedures and GMP/GDP standards
• Responsible for stopping and renewing production with accordance to West requirements and with MQ manager approval.
• Manage production relates projects and act as MQ focal point in various internal and external projects- such as Data Integrity, CoPQ, production improvement plans, etc.
• Provide Quality oversight of validation activities and processes.
• Lead pilot processes which include change and approval of quality aspects in pilot protocols and reports and assure that pilot processes are conducted according to West guidance and protocols.
• Attend production pilot meetings as the MQ focal point.

B.Sc. in Science or Engineering

• 3years of experience in Medical Device Quality & Productionifecycle
• Relevant work history and/or experience may be considered in lieu of degree
• Experience with production processes and process controls
• Experience with sub contractors interface and meeting customer expectations
• Experience with Medical Device, Validation Activities, Risk Management, Product Transferto production
• Working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971, MDSAP
• Must have effective problem solving and interpersonal skills
• Ability to work independently, multi-task and thrive in fast-paced environment
• Problem solving including root cause failure analysis methods

• Previous experience with MasterControl, Share Point, Teamcenter- a plus
• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Must maintain the ability to work well with others in a variety of situations
• Maintain high attention to detail, accuracy, and overall quality of work
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Observe and interpret situations, analyze and solve problems
• Effectively communicate and interface with various levels internally and with customers
• Certified auditor- a plus
• Relevant work history and/or experience may be considered in lieu of degree

• Must maintain the ability to work well with others in a variety of situations.
• Must be able to multi-task, work under time constraints, problem solve and prioritize.
• Self-motivated with the ability to make independent and sound judgments.
• Read and interpret data, information, and documents
• Learn and apply new information or skills

• Collaborate with R&D Associates to determine/develop design-around formulations.
• Collaborate with outside counsel to determine/develop invalidity positions to relevant patents.
• Determine launch strategy, including labeling carve outs, and assess risk associated with launch.
• Manage European Patent Office Oppositions and similar actions in national patent offices.
• Manage Unified Patent Court revocations.
• Collaborate with colleagues in other teams to ensure all global issues are addressed, including manufacturing site, device, and API issues.
• Collaborate with Regulatory Affairs Associates to support regulatory submissions.
• Collaborate with Portfolio Team to support identification of potential generic products for Teva’s European and International markets including providing IP landscapes and IP launch scenarios.
• Collaborate with Business Development to determine launch strategy, including labeling carve outs, and assess risk associated with launch for in-licensed generic products.
• Collaborate with Medis to support Medis’ out-licensing of Teva’s generic products.
• Manage outside opinion counsel to ensure high quality work product on time and within budget.

• Collaborate with R&D Associates to determine/develop design-around formulations.
• Collaborate with outside counsel to determine/develop invalidity positions to relevant patents.
• Determine launch strategy, including labeling carve outs, and assess risk associated with launch.
• Manage European Patent Office Oppositions and similar actions in national patent offices.
• Manage Unified Patent Court revocations.
• Collaborate with colleagues in other teams to ensure all global issues are addressed, including manufacturing site, device, and API issues.
• Collaborate with Regulatory Affairs Associates to support regulatory submissions.
• Collaborate with Portfolio Team to support identification of potential generic products for Teva’s European and International markets including providing IP landscapes and IP launch scenarios.
• Collaborate with Business Development to determine launch strategy, including labeling carve outs, and assess risk associated with launch for in-licensed generic products.
• Collaborate with Medis to support Medis’ out-licensing of Teva’s generic products.
• Manage outside opinion counsel to ensure high quality work product on time and within budget.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

• Collection and preparation of documents intended for submission of CMC variation packages
• Evaluation of changes and support for their implementation in drug documentation for EU, US, IL market, as well as monitoring the status of requests and agreed activities
• Participation in meetings for projects within responsibility and informing other organizational units about the content of the registration file
• Work with regulatory team and other functions to create solutions and implement agreed mitigation plans
• Provide regulatory input throughout the product life cycle of responsible product lines and understand or raise regulatory obstacles to Head of regulatory Function
• Preparation of responses to authorities’ requests within regulated timeframe
• Update status through electronic systems, database and relevant forums

• University degree (Pharmacist/Biologist/Chemist/ Engeneering/ Biomedical)
• 2-3 years of experience in regulatory affairs in CMC, quality assurance and control, drug development or analytics will be an advantage
• Experience of working with Multi-national companies in Pharmaceuticals
• Knowledge in regulation, requirements and guidelines
• Proficiency in written and spoken English and Hebrew
• Ability to work in dynamic environment, multi-tasking,
• Ability to work both individually and in the team, to cooperate on cross-country level and with different business units
• Experience in global environment- advantage
• Experience with sterile products
• Experience with medical device combined product- advantage
• Knowledge with electronic systems and databases

Assoc Dir Regulatory Affairs

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.