May 27, 2022

Job Description

$48 billion healthcare giant Novartis AG, headquartered in Basel (Switzerland), incorporated as a company in 2001 with the vision to centralize and harmonize all similar processes from all the 140+ countries and region offices that Novartis AG operates in across all its divisions.

Position Purpose:

• Follow up on the processes, procedures and activities related to the administration of the analytical technology implemented for the analysis and control of medicines, ensuring compliance with local, regional and global quality standards.
• Collaborate in the definition and implementation of the GxP analytical technology strategy installed within the region, which ensures compliance with local, regional and global regulations and standards with a minimum interruption of the routine operation of the Control laboratories. Quality.
• Coordinate and execute the strategies and activities related to the implementation, calibration, qualification, and validation of GxP instruments, equipment, critical systems, and computerized systems, in accordance with local, regional, and global standards and guidelines.

Major Accountabilities:

• Carry out and/or verify the issuance and/or update of the guidelines, regulations and policies related to drug analysis, in accordance with local, regional and global standards.
• Maintain a constant update of the regulations and standards of the health authorities applicable in the region and of corporate standards, with the aim of ensuring and standardizing compliance in the region.
• Issue, update, review and approve policies, standard operating procedures and work instructions, guaranteeing safe, reproducible processes that comply with the standards of regional and global health authorities.
• Plan, coordinate and execute analytical technology validation activities in close collaboration with QC and third-party service providers, ensuring compliance status of all installed technologies prior to use for product quality determination.
• Issue, review and/or approve the protocols and reports of calibration, qualification, validation for the instruments, equipment, critical systems and computerized systems of the QC laboratories, ensuring an approach in accordance with the regulation and compliance throughout the region
• Establish and timely verify the execution of all the CAPA derived from findings in the routine analytical operation or in local, global, internal and external inspections.
• Collaborate in the timely resolution of findings detected or presented during the analytical operation.
• Propose, lead and/or actively participate in initiatives and projects to improve Quality Assurance at a local, regional and/or global level (for example, NETLab, Data Integrity, Lean Excellence in Laboratories, 5S, etc.)
• Implement the strategy and actions for the regional projects of digital Quality Assurance solutions, to create a more productive and efficient environment in the QC laboratories in accordance with the general strategy of Novartis Digital QC.
• Analyze, evaluate, detect and propose solutions for the mitigation of data integrity risks during the use of analytical technology
• Collaborate in maintaining the analytical technology life cycle at the local level in line with regional and global strategies.
• Collaborate in the execution of tasks related to the administration of computerized systems in collaboration with the Owner of the System, such as User Administration, Periodic Review of Users, review of the Audit Registry, etc.
• Assist and support internal and external audits related to QA, QC, AS&T, and Data Integrity.
• Monitor the use of installed analytical technology capacity and establish strategies to maximize it.
• Collaborate with QC laboratories in the creation and execution of analytical technology validation programs.
• Ensure that all GxP computerized systems are installed and managed in accordance with Novartis standards and/or applicable regulations. Ensuring that all applicable users have access to these systems with appropriate permissions. Collaborate with applicable teams to ensure validation of computerized systems.
• Ensure that preventive-corrective maintenance activities are executed in a timely manner, contacting and negotiating efficient response times with service providers.
• Comply with the Health, Safety and Environment guidelines and policies, as well as with those for Information Security Risk Management, Good Laboratory Practices and Good Documentation Practices.

Diversity & Inclusion / EEO

Novartis se compromete a crear un entorno de trabajo excelente e inclusivo y un equipo diverso que represente a los pacientes y las comunidades a las que servimos.

Minimum Requirements

• Bachelor's degree related to Chemistry, Pharmacy, Biology or related field.
• English: advanced
• Minimum of five years in the Pharmaceutical Industry in areas such as Validation, CSV, Quality Control, Quality Assurance and/or Manufacturing.
• Knowledge of analytical and pharmaceutical technology.
• Knowledge of regional and global regulations applicable to the control, storage and distribution of pharmaceutical products.
• Validation of analytical technology (Equipment, Computerized Systems, Critical Systems)
Novartis Technical Operations
Buenos Aires
Tiempo completo
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Validation Specialist

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