QA Specialist Trainee

Chez Roche, vous pouvez être vous-même et être apprécié pour les qualités uniques que vous apportez. Notre culture encourage l'expression personnelle, le dialogue ouvert et les connexions authentiques, où vous êtes valorisé, accepté et respecté pour ce que vous êtes, vous permettant de prospérer tant personnellement que professionnellement. Voici comment nous visons à prévenir, arrêter et guérir les maladies et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Rejoignez Roche, où chaque voix compte.

Purpose

• Responsible for the maintenance and continuous improvement of the Change Control systems and processes.
• Ensure GMP compliance with the change control process.

• Technical and Functional: Ensure adherence to the Change Control management systems and processes
• Develop competency and proficiency in the QA Change Control process and the associated tools, supporting the delivery of training for change users as needed
• Evaluate Change Control requests for process, validation, regulatory and product impact
• Coordinate the review and approval process of change requests to ensure timely execution of changes
• Ensure all site major changes are managed appropriately to meet the expectation of the global change control board and meet site project timelines
• Participate in cross functional and cross site change management forums
• Collaborate with departments to ensure change control activities are executed efficiently and effectively, to provide supporting assistance to stakeholders in the process
• Ensure completion of required change control actions prior to lifting lot disposition restrictions
• Assist in the development and delivery of training materials and qualifications for Change Control processes and Change Management applications
• Perform Change Records review in support of Annual Product Review activities
• Ensure maintenance and continuous improvement of change control and processes
• Support regulatory inspections and provide audit support, which may include facility, utility, equipment documentation review
  • Safety, Health & Environment: Comply with all RSTO's Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable
  • Observe all RSTO's site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.
    • Lean Production System: Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviours through the use and application of LPS tools for continuous improvement initiatives.
    Key Interfaces
    • Manufacturing, Local MSAT, Engineering
    • Quality Functions (e.g. QA Ops, QC)
    • Global Change Management BPOs and BPMs
    • PT Regulatory
    Qualifications
    • Education: Diploma/Degree in Engineering or Science discipline is preferred
      • Experience (may vary depending on site size/scope): Fresh graduates/mid-career professionals who are switching out of other industries
        • Knowledge/Skills/Competencies
          • Strong knowledge in Change Control principles, practices and standards for the pharmaceutical industry
          • Strong knowledge of cGMP regulations relevant to the pharmaceutical industry
          • Systematic, meticulous and analytical approach to evaluation and execution of tasks
          • Demonstrate excellent verbal and written communication skills in English
        Qui nous sommes
        

Un avenir plus sain nous pousse à innover. Ensemble, plus de 100 000 employés à travers le monde sont dédiés à faire progresser la science et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Nos efforts aboutissent à plus de 26 millions de personnes traitées avec nos médicaments et plus de 30 milliards de tests réalisés avec nos produits de Diagnostique. Nous nous encourageons mutuellement à explorer de nouvelles possibilités, à favoriser la créativité et à conserver nos grandes ambitions, afin de fournir des solutions de santé qui changent des vies et ont un impact mondial.

Construisons ensemble un avenir plus sain.

Roche est un employeur offrant l'équité en matière d'emploi.