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**Job Description**:PRINCIPAL RESPONSABILITIES:- Ensure that the Quality System Management is aligned with GMP/GLPs and corporate guidelines, establishing processes to ensure periodic review of local and international regulation and its implementation in the Quality Control laboratories.- Assure all the products in the market are testing according to the regulations required by the countries where Organon Mexico 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.EXPERIENCE:- 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%+**Secondary Job Description****Who We Are**: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.
We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.
Our Vision is clear: A better and healthier every day for every woman