This role gives you the opportunity to lead key activities to progress YOUR career, the main of these are to provide 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 Quality function and 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 is complying 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 team develop 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.Ensure 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, ensure risks are identified and managed through the Risk Management System.Ensuring Quality budget is adequately planned for and executed.Why you? Basic Qualifications: 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 in respect of both product quality and staff safety.Competent in the interpretation of data and regulations and the assessment of risk.Project management.Level of English in terms of 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.Project management.Strong influencing skills at senior levels.If you feel this is your next career move, please apply up to August 16, 2024.
Why GSK? GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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