(Sr.) Quality Partner

At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

The Position

Job Summary职位概述:

Overview总览

• Review/approval qualification & validation documents in the area: system qualifications / process
• Be responsible to support project and qualification and validation activities and equipment facility and clean utility change control management
• Ensure that the process is complies with the requirements of European US China and International cGMP regulations and the requirements from Roche Global Standard Process or Divisional Quality Standard.
• Handling NC and CAPA related to identifiedarea in RDSZ meets therequirements of European US China and International cGMP regulations and the requirements from Roche Global Standard Process or Divisional Quality Standard.

• The requirementsareimplementedeffectively and elements of the identified areas in RDSZ qualitymanagement systems and are continuouslyimproved.

• The relevant quality assurance principles e.g. concerningnonconformityreporting CAPA are implemented.

The What做什么

• Perform activities as required to meet Quality goals and objectives independently. Able to identify improvements and implement with collaboration from supervisor. Navigates in complex situations by applying a diverse skillset.
• Prepare documentation for and participate in audits as applicable.
• Document authoring and review as required to support changes. Performs technical reviews as applicable. May require collaboration with supervisor on technically complex technical reviews independently.
• Complete all required training in learning solution.
• Responsible for training coaching and mentoring other quality managers or business partners as applicable in a professional manner to ensure that business needs are being met.
• Able to troubleshoot issues as they arise develop and independently implement solutions to ensure that daily work is completed without jeopardizing compliance.
• Ability to work day to day with minimal to no supervision to correctly complete daily scheduled and unscheduled activities. Initiates activities independently and initiates interactions across departments as applicable. Initiates daily activities independently. Has courage to make decisions even outside of scope/comfort zone. Is decisive and does not procrastinate on decisions; develop solutions and presents both issues and solutions to supervisor.
• Identify Initiate facilitate participate and implement process improvements to meet business needs. Able to link responsibilities with both site and Global Quality and Regulatory. Drive innovation across the local organization/site.

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.