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* Serve as the first point of escalation for technical, compliance, and personnel problem resolution.
* Lead, plan, and coordinate routine team activities to meet business needs.
* Perform QC Chemistry analysis of incoming goods, in-process samples, intermediates, and finished product samples to Good Manufacturing Practice (GMP) standards.
* Conduct GMP analysis of stability samples.
* Complete, update, and review technical documentation, including analytical write-ups, standard operating procedures, and GMP forms.
* Verify and calibrate lab equipment.
* Maintain up-to-date training in line with GMP expectations.
* Manage QC chemical, reference standard, and consumable stock levels.
* Perform or coordinate QC batch release procedures and deliver lab throughput in line with the business plan.
* Manage and coordinate stability studies in compliance with business procedures and ICH guidelines.
* Maintain a thorough understanding of international regulatory requirements and act as a Subject Matter Expert during audits and inspections.
* Collaborate and coordinate initiatives with other QC Supervisors and Managers for improved compliance, efficiency, and working conditions.
* Identify and drive Practical Process Improvement (PPI) initiatives.
* Undertake ad-hoc activities as required by the business.
* Support and encourage a "Quality Culture" throughout QC.
* Deputize for the QC Manager in their absence.
Requirements:
* Degree in Chemistry or a strongly related scientific subject area, or equivalent experience.
* At least five years of relevant industrial experience.
* Extensive experience in instrumental and traditional analytical techniques.
* Supervisory experience is desirable.
* Effective communication skills at all internal and external levels.
* Proficient time management and project management skills.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
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