Kenvueは現在、以下求人を募集しております。
Junior ‘Qualified Person’ & Commercial Quality Specialist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:
Commercial Quality Manager - Iberia場所:
Europe/Middle East/Africa, United Kingdom, Reading, Berkshire勤務地:
ハイブリッドあなたがすること
This role is able to offer a positive work life balance and flexible/hybrid working. It may also be suitable for a newly certified ‘QP’ .
The role:
This position will act as Qualified Person for UK ensuring the batch certification of medicinal products manufactured and/or imported under the UK MIA in accordance with The Human Medicines Regulations 2012 and EU GMP, including Annex 16.and local procedures. This position will also act as Responsible Person back-up to the current Responsible Person for the UK market.
The position maintains understanding and awareness of current and emerging regulations applicable to the Qualified Person role, MIA License and GMP requirements and the impact to quality practices.
This position is responsible for the oversight and execution of the Quality Management Systems and Compliance at Kenvue, identifying opportunities for continuously improvement, consistent with the company’s business objectives.
The position implements departmental strategies and serves as a point of contact to the corresponding country operational teams on Quality related matters and will liaise with multiple Quality organizations to drive timely resolution of Quality related issues.
The position optimizes quality systems and processes and ensures alignment with the worldwide business, applicable local regulations and the quality vision and/or Policy, and provides a measurable impact to quality, cost, and customer value.
It also identifies significant business issues, prioritizes actions, leads and supports improvement opportunities and problem resolutions.
The position plans, coordinates, and directs quality assurance programs designed to ensure effective and consistent processes with established standards by performing the following duties personally or with colleagues. It also supports departmental goals and objectives, and business measurements for department.
Key Responsibilities
Quality Management
Batch certification of medicinal products manufactured and/or imported under the MIA.
Responsible for the maintenance and implementation the local Quality system
Support the management, escalation, resolution and communication of quality issues
Responsible for the qualification and approval of quality impacting suppliers, including maintaining the required associated documentation such as Quality Agreements
Support regulatory submissions and changes to supply chain by preparing and approving QP declarations.
Assess proposed changes to MA and provide impact assessment.
Liaise with RA team to ensure prompt implementation of variations to MA.
Oversight of products supply chain
Processes
Maintain compliant and effective procedures to meet the business needs
Assist in the local implementation of regional procedures
Develop, update, review and approve effectively all local procedures, work instructions and associated documentation
Where requested provide input to draft global / regional procedures
Provide Quality related input to marketing, sales and distribution activities/systems
Approve Finished Good Specifications
Preparing data collection, reviewing and approving PQRs.
Repack-Relabel, Co-packing and Warehousing
Oversight of products storage and distribution according international and local regulations
Defining, designing, and implementing quality requirements for repackaging and relabelling operations according to product owner specifications and local regulations
Evaluating product impact and execution of product disposition when applicable
Quality Management Systems
Responsible for management of Quality systems, including Nonconformances and CAPA process and systems, Procedural documents, document management, Change Control, Training management, Supplier and Customer management and qualification.
Responsible for ensuring the appropriate handling of quality related customer and consumer complaints including track and trend, and mitigation of related issues
Provide input into development projects, approval of artwork changes, management of quality issues and complaints, product recalls, interface with official organisations, internal Quality groups, supplier sites and ensure internal quality standards are adhered to.
Responsible for oversight and management of key Quality System elements, where requested by Cluster Head.
Compliance
Preparing and attending Quality Management Reviews.
Provide support to the successful management of all Health Authority or external agency inspections as well as quality related internal audits (e.g. GRC, BRQC).
Responsible for the proactive identification and mitigation of compliance risk through internal audits and other compliance programs.
Responsible for evaluating the company’s quality and distribution process capabilities against company and industry standards and regulatory expectations.
Act as Qualified Person named on the UK MIA license, including all required tasks of a Qualified Person
Act as backup Responsible Person named on the WDA UK License
Responsible for preparing and hosting MHRA inspections
What we’re looking for:
Qualifications
Registered Qualified Person in UK
Registered Responsible Person in UK
Meet the MHRA eligibility criteria to be named on a UK Manufacturer’s Authorisation.
Strong regulatory knowledge, licence maintenance and issue management
Proven track record in Continuous Improvement and Quality Systems.
Previous experience interfacing with regulatory agencies, and a history of contributing to success in resolving complex regulatory compliance issues.
Experience in KPI frameworks, QSMR, Change Control, Audits, and CAPA.
Competencies
Knowledge of the manufacture and packaging processes of pharmaceutical products
Experience with solid and liquid dosage products
Experience with matrix organisation Strategic Quality Management with business outcome focus.
Analytical strength, prioritization, and structured problem-solving.
Effective communication and change management skills
Organization and ability to work in complex and virtual environments
Strong technical writing and data storytelling skills.
Fast risk based decision-making skills
Languages
Fluent English; additional EMEA languages a plus.
What’s in it for you
Competitive Benefit Package
Paid Company Holidays, Paid Vacation, Volunteer Time & More!
Learning & Development Opportunities
Kenvuer Impact Networks
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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