Kenvueは現在、以下求人を募集しております。
Quality Specialist II (Validation - 24 month contract)私たちがしていること
私たちKenvueは、日々のケアが持つ驚くべき力を信じています。100年以上の伝統と科学に根ざし、Neutrogena®, Aveeno®, Tylenol®, Listerine®, Johnson’s® and BAND-AID®など、皆様が既にご存じでご愛用いただいているアイコニックなブランドを提供しています。科学は私たちの情熱であり、ケアは私たちの才能です。
Who We Are
私たちのグローバルチームは、インサイトとイノベーションに情熱を注ぎ、最高の製品をお客様にお届けすることに全力を注ぐ、多様で優秀な22,000人以上の社員で構成されています。専門知識と共感力を備えたKenvuerであることは、毎日何百万人もの人々の生活に影響を与える力を持つことを意味します。私たちは、人を第一に考え、全身全霊をもってケアし、サイエンスで信頼を獲得し、勇気をもって解決します。私たちとあなた自身の未来を、共に切り開いていきましょう。
Role reports to:
Supervisor II, Validation場所:
North America, Canada, Ontario, Guelph勤務地:
ハイブリッドあなたがすること
Please note this is a 24 month fixed term contract.
The Quality Specialist II (Validation) will support and co-ordinate activities associated with cleaning, manufacturing and packaging processes, computer systems, analytical and microbial method, shipping, facility, utility and equipment qualifications for the Guelph site.
The Quality Specialist II will coordinate the development, creation, review and approval of qualification and validation documents (protocols, reports, validation assessments, technical reports, and user requirements, function and design specifications).
They will ensure that documented evidence exists to provide a high degree of assurance that processes, equipment, computer systems and methods are consistently reproducible and meet Kenvue policies and quality standards, health, safety and environmental regulations, and regulatory requirements (e.g. Health Canada and the United States FDA).
The Quality Specialist II will collaborate with stakeholders to develop and administer validation policies, including the deployment of these policies
Key Responsibilities
Review, revise or approve validation documents (ie. assessments, documents, protocols, reports, etc.) to ensure they are in compliance with relevant SOPs, government regulations, and company policies. This includes documents executed at Kenvue – Guelph Campus and /or specific business partners and contract sites. Validation types may include but are not limited to: packaging validation; cleaning validation; process validation; analytical and microbial method validation; shipping qualification; equipment qualification; and computer validation.
Represent Quality & Compliance on taskforces / committees for base business, new product introduction and capital projects. Connect with SMEs as appropriate to ensure transfer of knowledge and action on key deliverables.
Create, review and/or approve other site documents, such as: GCC assessments, Annual Product Quality Reports (APQR), Master Batch Records, SOPs etc.
What we are looking for
Required Qualifications
Minimum degree in Science/Engineering or related discipline
Minimum 3-5 years of relevant experience in Quality, R&D or Production environment in the pharmaceutical industry.. Validation experience in the pharmaceutical industry an asset.
Ability to evaluate scientific data.
Ability to take ownership for work independently on project activities.
Excellent communication and presentation skills.
Knowledge of and competence in the application of Health Canada GMPs, CFRs and ICH Guidelines.
Must be able to influence and facilitate groups with diverse perspectives and bring teams to consensus / alignment.
Strong leadership, organization, decision making and interaction management skills.
Strong computer skills, specifically in Microsoft Word, Excel, and Adobe Acrobat.
Strong technical writing, verbal communication, interpersonal and problem solving skills.
What’s in it for you
Competitive Benefit Package*
Paid Company Holidays, Paid Vacation, Volunteer Time & More!
Learning & Development Opportunities
Kenvuer Impact Networks
This list could vary based on location/region
*Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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