Job Description

Bei Roche kannst du ganz du selbst sein und wirst fur deine einzigartigen Qualitaten geschatzt. Unsere Kultur fordert personlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du fur das, was du bist, wertgeschatzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl personlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat - heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zahlt.


Die Position

1) Purpose

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

2)

Key Responsibilities

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 meets 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.

3) Key Interfaces:

Manufacturing, Local MSAT, Engineering Quality Functions (e.g. QA Ops, QC) Global Change Management BPOs and BPMs PT Regulatory

4) 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 of 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


Wer wir sind
Eine gesundere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat - heute und fur zukunftige Generationen. Durch unser Engagement werden uber 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgefuhrt. Wir ermutigen uns gegenseitig, neue Moglichkeiten zu erkunden, Kreativitat zu fordern und hohe Ziele zu setzen, um lebensverandernde Gesundheitslosungen zu liefern.


Gemeinsam konnen wir eine gesundere Zukunft gestalten.

Roche ist ein Arbeitgeber, der die Chancengleichheit fordert.