Job Description

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Responsible for providing expertise in Quality Assurance processes related to the manufacture of West products. Ensure compliance to regulatory requirements and West procedures. Proactively develop, lead, and drive the execution of the Quality Assurance strategy. Develop and implement quality assurance plans ensuring compliance with regulations, oversee interactions with regulatory agencies and build strong relationships with internal and external stakeholders. Champion advocacy for product, process, and system quality, and drive continuous improvement within the Quality Management System.

Essential Duties and Responsibilities

Le poste a pour mission principale de garantir la conformité des projets CAPEX, des programmes industriels et des processus qualité du site aux exigences internes West et aux normes réglementaires (GMP). Il contribue activement à l’amélioration continue, notamment à la réduction du Coût de Non-Qualité (CoPQ), par une approche analytique et préventive basée sur la gestion des risques.

Le poste couvre notamment les missions suivantes :

- La représentation du département Qualité dans les projets majeurs (CAPEX, nouveaux équipements, programmes).

- La définition, le pilotage et l’amélioration des processus qualité via des KPI et des audits internes.

- La gestion de la stratégie de validation (Site Validation Plan) et l’approbation des dossiers de validation.

- La supervision du programme local d’intégrité des données en collaboration avec les spécialistes GMP.

- Le support aux activités du laboratoire (déviations, OOS).

- La conformité documentaire (APR, DMF, SOI, création/modification d’articles).

- La mise en œuvre d’une démarche structurée de gestion des risques (FMEA, maintenance préventive, plans de calibration).

- le management de l’équipe Qualité Système et de la Métrologie ...

Additional Responsibilities

Le poste exige une solide expérience en Assurance Qualité (>5 ans), une bonne maîtrise des réglementations GMP, des compétences analytiques fortes, ainsi qu’une capacité à évoluer dans des environnements complexes et transverses.

L’anglais courant et la maîtrise des outils bureautiques et SAP sont requis

Education

• Formation universitaire Bac +4/5 ou équivalent en qualité, chimie ou ingénieur généraliste.

Work Experience

• Minimum 5 ans en qualité en industrie alimentaire, cosmétique ou le pharmaceutique

Preferred Knowledge, Skills and Abilities

• Expertise in quality management tools and supply chain methodologies – APQP, PPAP, MSA, SPC.
• Strong working knowledge of quality systems such as ISO 13485, ISO 9001, ISO 15378, 21 CFR 820, ISO 14971
• Working knowledge of supplier quality management from product development to high volume production
• Strong project management skills, communication skills, problem solving, and interpersonal skills.
• Able to exhibit a strong “quality first” mindset and ensure that product and process quality are held to the highest standard.
• Ability to work independently, multi-task and thrive in fast-paced environment.
• Strong problem-solving skills including root cause failure analysis methods.
• Proficient in statistical software, Windows OS, Microsoft Office: Word, Excel, Power Point, and Teams
• Be aware of all relevant SOPs as per Company policy as they relate to this role.
• Able to comply with the company’s safety policy at all times.
• Strong project management skills
• Previous experience with MasterControl, SAP, SharePoint, Teamcenter

West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening.