Job Description:
As a Commissioning and Qualification (C&Q) Specialist at Novartis Pharma Schweiz, you will play a critical role in ensuring the smooth operation of our pharmaceutical facilities.
Major Accountabilities:
* Protocol Development: Prepare, execute, and compile commissioning and qualification protocols and reports for pharmaceutical facilities, including manufacturing facilities. Develop commissioning and qualification standard operating procedures and work instructions.
* C&Q Activities: Provide on-site support for C&Q activities, adhering to ISPE/ASTM methodologies, utilizing GDP, GEP, C&Q baseline guides, GAMP 5, and cGMP principles. Stay up-to-date with regulatory guidelines from USFDA, MHRA, WHO, ISO, and 21 CFR part 11.
* Deliverables Planning and Execution: Plan, develop, execute, and report C&Q deliverables.
* Validation Master Plan and Documents: Prepare and review validation master plans, validation plans, and validation documents. Execute clean room and HVAC system commissioning and validation according to required standards.
* Pre-commissioning and Commissioning Checklists: Prepare and execute pre-commissioning and commissioning checklists for various systems, including facility and process/utility equipment.
* FAT/SAT/IOQ Protocols/Reports: Prepare and execute facility, utility, and process equipment FAT/SAT/IOQ protocols/reports.
* SOP Development and Maintenance: Improve and optimize qualification activities, modify SOPs as needed, document periodic reviews for manufacturing equipment and utilities, and maintain documentation packages for qualification and periodic reviews.
* Quality Management System Implementation: Maintain procedures in compliance with the Engineering department's quality management system. Introduce and implement changes as required.
Essential Requirements:
* Education: Degree in Mechanical or Chemical Engineering.
* Experience: 8-10 years of experience in the pharmaceutical, chemical, or FMCG industry.
* C&Q Knowledge: Deep understanding of project commissioning and qualification activities, including facility/HVAC/clean room/black and clean utility services/process equipment within the pharmaceutical industry.
* Project Management: Good knowledge of project management principles, including project planning, cost management, time management, construction management, quality management, contract administration, safety management, and statutory approvals management.
* Language Skills: Fluent in English and Spanish, written and spoken.
About Us:
At Novartis Pharma Schweiz, our purpose is to reimagine medicine to improve and extend people's lives. We strive to become the most valued and trusted medicines company in the world. Our associates drive us to reach our ambitions, and we invite you to be a part of this mission.
Benefits and Rewards:
We offer a range of benefits and rewards that will help you thrive personally and professionally. Learn more about them in our handbook.
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.