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The Lab Compliance Manager role is pivotal in driving project-related activities within the QC department, focusing on innovative analytical techniques, automation, and a paperless lab environment.
This position is crucial in implementing the 'Lab of the Future' concept and managing lab expansion projects. The Lab Compliance Manager will lead and manage all project-related activities in the QC department, overseeing the introduction of new analytical techniques, focusing on automation and paperless laboratory systems.
Main Responsibilities:
- Lead and manage all project-related activities in the QC department, including leading and managing cross-functional teams to facilitate project goals and timelines.
- Oversee the introduction of new analytical techniques, focusing on automation and paperless laboratory systems.
- Manage the implementation of the Lab of the Future initiative in the QC department, ensuring delivery of training curricula for QC via laboratory trainer role.
- Coordinating and overseeing laboratory expansion projects, including managing compendial reviews, documentation control for QC, maintenance and calibration of analytical instrumentation, analytical work orders on Maximo, and retention management.
- Manage purchasing and budget control, including vendor-managed inventory, laboratory cleaning services, and capital requirements for QC, ensuring compliance with data integrity policies and regulatory requirements.
- Liaise with PDS&T to ensure execution of reference standard interval testing programs, presenting project updates and technical data to stakeholders effectively.
- Lead operational excellence in QC, delivering on various initiatives, including reduced testing programs for QC, inspection readiness in QC, participating in internal and external audits, and addressing audit findings.
Requirements
- Bachelor's or Master's degree in Chemistry or a related discipline.
- Experience working in API and OSD QC laboratories.
- Minimum 4 years of experience in people management within a QC lab setting.
- Strong project management, presentation, and communication skills.
- Innovative thinking, with a commitment to advancing laboratory practices and compliance.
Benefits:
The successful candidate will be responsible for ensuring delivery of high-quality results, developing and maintaining effective relationships with team members and stakeholders, and contributing to a collaborative and inclusive work environment.
The ideal candidate will possess excellent communication and interpersonal skills, be able to work effectively in a fast-paced environment, and have a strong passion for quality assurance and compliance.
