TRD RLT Pilot Plant QC Supervisor
TRD RLT Pilot Plant QC Supervisor
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Job Description
Job Description Summary
Coordinating QC laboratory activities responsible to ensure compliance to cGxP and Novartis standards for topic within area of responsibility (during development transfer release and stability) including safety testing monitoring and trending. Participating to Pilot Plant build-up phase as key team member for GMP quality control laboratories as well as support for development laboratories.Provide guidance support and leadership for implementation of analytical standards.
Job Description
Key Responsibilities:
Ensure quality compliance and efficiency in team operations while aligning with site strategies.
Act as the primary contact to address and manage laboratory issues related to equipment analysis compliance and operational challenges.
Plan and coordinate lab activities ensuring timely release of materials and products proper inventory management and adherence to site lead times.
Create capacity plans to meet business objectives optimize laboratory performance and proactively ensure team compliance with HSE and operational procedures.
Oversee analytical activities including data review batch release analytical method lifecycle (validation transfer troubleshooting) and stability studies in collaboration with the Analytical Development Team.
Maintain inspection readiness supervise compliance with cGxP Good Laboratory Practices (GLPs) ALCOA principles and manage deviations CAPAs and Change Controls as required.
Lead and develop team members by monitoring training compliance ensuring qualifications for GMP tasks fostering a culture of engagement and accountability and supporting talent development.
Promote a positive and motivated work environment by providing constructive feedback coaching and modeling cultural aspirations aligned with company values.
Essential requirements:
Masters degree (preferred) or equivalent in Pharmacy Chemistry or a similar scientific field.
5 years of experience in a similar role within a GMP-regulated laboratory environment.
Strong background in analytical laboratory operations and quality management systems with knowledge of Good Documentation Practices and Data Integrity principles.
Experience in the nuclear medicine industry (preferred).
Highly organized detail-oriented and accuracy-focused with the ability to work independently as a self-starter.
Proven personal ethics responsibility and dedication to purpose.
Excellent written and verbal communication skills including experience interacting professionally with external vendors or business partners.
Strong familiarity with GMP compliance and laboratory workflows.
Why Novartis Our purpose is to reimagine medicine to improve and extend peoples 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: will receive: You can find everything you need to know about our benefits and rewards in the Novartis Life
:// 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.
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Coaching Skills Data Science Environment Experiments Design Health And Safety (Ehs) Laboratory Equipment Manufacturing Process Materials Science Process Simulation Sop (Standard Operating Procedure) Technical Writing Waterfall ModelRequired Experience:
Manager
Employment Type
Full-Time
