摘要
About the Role
The responsibilities of the C&Q Engineer includes but not limited to:
- Ensure commissioning and qualifications are in compliance with Quality Manual/Quality Modules/STDs/GOPs/site SOPs etc. Create & revise relevant SOPs for commissioning & qualification.
- Perform gap assessment due to revision of GOP and Work procedures etc.
- Annual update of Master Equipment Inventory (MEI) in COMOS
- Drafting of all required Commissioning & Qualification Deliverables (e.g URS, GMP-FRA, Concept Paper, Qualification Plan, Commissioning Test Plan, CTS, Design Qualification, TSIQ, TSOQ, TSPQ, CIP, SIP, Sterile Hold Studies, Qualification Release documents, Qualification Summary Reports etc etc)
- Perform Pre-Requisite checks for each Commissioning & Qualification Phases prior to protocol execution and support routine maintenance of the validated system status (e.g Periodic Review etc) thereafter
- Drafting of project documents (e.g Project Quality Plan, Master Qualification Plan, etc). Management of project deficiencies, project deviations, 1QEM (Deviation) etc and lead investigation (e.g root cause analysis) during commissioning & qualification. Perform project reviews/audit (e.g. Technical Quality Review (TQR), constructability, sustainability, HSE etc)
- Engineering compliance oversight for approval of Equipment/Instrument Data Form & Spare parts material master change request form from all functions. Conduct regular compliance self-inspection within Engineering functions
- Perform monthly checks on CSE PM01 & PM02 Work Orders in SAP to check for overdue and provide data for monthly SQC reporting.
Requirements
- Degree in engineering (Dipl. Ing. / M. Sc. / B. Sc.) or equivalent
- Fluent in English and proficient in local language.
- > 5 years of engineering project/commissioning /qualification /Compliance in Pharma
- Excellent technical knowledge with demonstrated ability to deliver safe, effective and fully compliant projects
- > 5 years of demonstrated leadership abilities, leading both internal and external team members
- Excellent interdisciplinary knowledge (process, HVAC, automation, etc.)
- Outstanding GxP and regulatory knowledge
- Advanced HSE knowledge
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? http://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: http://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
