Quality Assurance Manager
hace 2 semanas
Job Title: Quality Assurance Manager
Job Summary:
We are seeking a highly skilled Quality Assurance Manager to join our team at Organon. As a Quality Assurance Manager, you will be responsible for ensuring that our Quality System Management is aligned with GMP/GLPs and corporate guidelines.
Key Responsibilities:
- Ensure that all products in the market are tested according to the regulations required by the countries where Organon exports and are aligned with current Worldwide Pharmaceutical Standards.
- Monitor, track, and design Quality Control KPIs, optimizing and seeking Operational Excellence.
- Lead Quality Control and Microbiological lab, empowering and fostering employees.
- Establish and ensure in Quality Control Area an effective Data Governance Management, information, physical, and Electronic Data according to corporate guidelines.
- Manage financial resources and budget of the quality Control Area, though the implementation of business needs and priorities of the area.
- Instill best practices and quality operations, ensuring Reliability, Efficiency, and safety through establishing processes, controls, and monitoring of regulation compliance and corporate guidelines.
- Promote teamwork, training, development, and motivation. Establishing the needs of technical and institutional training, Promote innovation and participation of their staff.
- Establish annual priorities for Quality Control Area, aligned to the business Quality Priorities.
- Performing constant benchmark with other Organon Sites to implement best practices, promoting changes in the staff responsibilities and training employees.
- Establish a culture of continues improvement to implement optimizations in processes, systems, and methods which increase productivity levels and level of service to internal and external customer in line with corporate guidelines and regulations.
- Ensure strict compliance with corporate standards and local regulations.
Requirements:
- Pharmaceutical Chemistry, Chemical Engineering Degree, and equivalent university degree in biomedical and/or life sciences.
- Minimum of 5 years in leadership roles in the Quality Control Area.
- Preferred of 5-8 years of experience in GLP in the pharmaceutical industry.
- Broad technical knowledge of Quality Control, Pharmaceutical manufacturing Industry.
- Familiarity with Mexican and International regulations related to quality Control in the Pharmaceutical Industry.
- Advanced English Skills 90%+.
About Organon:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families, and the communities they care for.
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