This role gives you the opportunity to lead key activities to progress YOUR career.
The main responsibilities include providing LOC SC (Local Operational Company Southern Cone) leadership and direction to ensure the highest standards of product quality and compliance with corporate and regulatory standards.
You will take responsibility for effective operation and performance management of the Quality function and be accountable for the implementation and maintenance of effective quality procedures to ensure compliance with GMP (Good Manufacturing Practices) & GSK Quality Management System and local regulatory requirements.
This role gives YOU the opportunity to lead key activities to progress YOUR career, the main of these are: Ensure SC (Southern Cone) quality organization complies with global quality model and sufficient resources; knowledge and expertise is available to assure the LOC meets its quality commitments.Ensure all quality policies are in place and in use, complying with regulatory and QMS requirements.Ensure all lab activities and quality assurance compliance requirements are in place to develop and maintain the systems, methods, processes, and equipment meeting Quality Management System and regulatory requirements.Ensure audit systems are in place and effectively applied with effective Correction and Preventive Actions to prevent recurrences.
Ensure the team develops effective Correction and Preventive Actions for each major or critical observation arising from L3 and L4 audit and ensure the closure within due date of CAPAs.Ensure capabilities of Quality Assurance and Quality Control staff, and all job competencies are identified, documented, and all training needs are defined in their training curricula.Ensure using product incident management (LIC (Local Incident Committee) / PIRC (Product Incident and Recall Committee) / Recall) to build focus on patient safety.Ensure a safe-working environment that complies with company EHS requirements.Chair the Quality Council process within the LOC (Local Operational Company) and play an active role in other governance committees as required.Prepare a strategic Quality improvement plan and annual objectives, in line with the GSF/PSC Quality Strategy; monitor performance and act to ensure that objectives are met.Accountable for LOC (Local Operational Company) KPIs performance.Establish and maintain a program to provide personal and professional development for the Quality staff, ensuring clarity of goals and objectives and providing regular monitoring and feedback on performance.Accountable for all quality risks, ensuring risks are identified and managed through the Risk Management System.Ensure the Quality budget is adequately planned for and executed.Why you? Basic Qualifications: We are looking for professionals with these characteristics to achieve our goals:
Bachelor's degree in health sciences (Pharmacy, Chemistry, Biochemistry) specialized in Quality Management.Knowledge and understanding of pharmaceutical quality management systems.Thorough understanding of regulatory and legal requirements regarding product quality and staff safety.Competent in the interpretation of data and regulations and the assessment of risk.Project management skills.Proficiency in English (speaking, writing, and reading).Computer Skills (Word, Excel & PowerPoint).Preferred Qualifications: Contribute towards creating and embedding a LOC SC (Local Operational Company Southern Cone) Quality culture.Strong verbal and written communication skills.Skilled in problem-solving and decision-making.Strong influencing skills at senior levels.If you feel this is your next career move, please apply up to August 16, 2024.
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