QA Engineer at West Pharmaceutical Services Cornwall Ltd

Raanana, Center District, Israel -

Full Time

Start Date

Immediate

Expiry Date

10 Jan, 26

Salary

0.0

Posted On

12 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Documentation, Validation, Calibration, Cross-Functional Collaboration, Risk Management, ISO 13485, 21 CFR 820, ISO 14971, Medical Device, Pharma Industry, Process Validation, Change Control, Lean Sigma, Problem Solving, Technical Writing, B.Sc. in Science or Engineering

Industry

Pharmaceutical Manufacturing

Description

Job Summary In this role, you will be supporting Engineering department as well as being involved in QA activities.Essential Duties and Responsibilities QA focal point for engineering projects. Provide guidance on documentation structures and formats to ensure compliance to procedures, relevant regulations, and standards. Participate in equipment and process validation (IQ, OQ, PQ) on site. Responsible for approval of engineering documentation - reviewing and approving technical, mold, test method, equipment and process validation (IQ, OQ, PQ) documentation. Assist and provide guidance on any out of specification result, deviation, or excursion that may occur QA representative in equipment development design reviews and in in equipment and process validation reviews. Responsible for calibration of inspection equipment, including the coordination of calibration with the calibration lab, follow up, approval of the calibration records and handling any calibration deviations. 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 Provide support, when necessary with review and approval of product development DHF documentation (DDP, PRD, TMX, URS, design verification & validation activities, dFMEA, pFMEA, FMEA risk documents, test methods, OOSs, protocols, reports, product design transfer) Support other QA dept activities, routine sterility validation (dose audit and bioburden) maintenance activities,etc Additional Responsibilities Education B.Sc. in Science or EngineeringWork Experience Minimum 2 years of experience in Medical Device Quality & Product Development Lifecycle Experience in Medical Device / Pharma industry Experience with Medical Device Design & Development, Verification Activities, Risk Management, Product Transfer, DHF Activities Experience in Equipment Validation, Process Validation, Change Control Process Strong working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971 Preferred Knowledge, Skills and Abilities Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description Support and contribute to Lean Sigma programs and activities towards delivery of the set target Able to comply with the company’s safety policy at all times Able to comply with the company’s quality policy at all times. Technical skills Written and verbal expression skills: Hebrew- Excellent, English- Excellent Relevant work history and/or experience may be considered in lieu of degree. License and Certifications Travel Requirements 10%: Up to 26 business days per yearPhysical Requirements Medium-Exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects.Additional Requirements 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 documentsLearn and apply new information or skills

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Responsibilities

The QA Engineer will act as the QA focal point for engineering projects, providing guidance on documentation and participating in equipment and process validation. They will also be responsible for reviewing and approving engineering documentation and assisting with any out of specification results.