摘要
About the Role
Major Accountabilities
- Responsible for Preparation/execution/compiling of Facility, Process, HVAC, Clean room and Utility Services Commissioning & Qualifications activities Protocols/reports for the Pharmaceutical facilities which includes manufacturing facilities. Preparations of Commissioning & Qualifications Protocols/ Standard operating Procedures/ Work instructions.
- Responsible for onsite support C&Q activities by following ISPE/ASTM methodologies utilizing GDP, GEP, C&Q Base line guides, GAMP 5 & cGMP Principles. In depth knowledge of Regulatory Guidelines- USFDA, MHRA, WHO, ISO, 21 CFR part 11 and other regulatory guidelines.
- Planning, developing, execution, reporting of C&Q Deliverables.
- Prepare/ Review of Validation master plan, Validation plans, Validation Documents, Commissioning & Validation execution of Clean Room & HVAC Systems (Such as DQ, IQ, OQ & PQ) in Pharmaceutical Industries as per the required standards.
- Preparations & execution of Pre-commissioning & Commissioning checklists for various systems including Facility & Process/Utility Equipments.
- Preparation & execution of Facility, Utility & process equipment FAT/SAT/IOQ Protocols/Reports.
- Improve and optimize based on requirements qualification activities and qualification activities, including modifying SOPs were required. Document periodic reviews for manufacturing equipment and utilities required onsite.
- Maintain documentation package for qualification, periodic reviews on time in compliance.
- Maintain procedures in compliance for Engineering department. Introduce and implement change when required following Quality Management System from Novartis.
Essential Requirements:
- Education: Degree in Mechanical/Chemical Engineering.
- 8-10 years of experience in Pharmaceutical/ Chemical/ FMCG Industry.
- Deep understanding of Project Commissioning & Qualification activities like Facility/HVAC/Clean room / Black & Clean Utility services/Process equipment within pharmaceutical industry.
- Good Knowledge of Project management like - Project planning, Cost Management, Time Management, Construction management, Quality Management, Contract Administration, Safety Management & required Statutory approvals management.
- Fluent in English and Spanish, written and spoken.
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: http://www.novartis.com/about/strategy/people-and-culture
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
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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
