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Summary
The Compliance specialist is responsible to collaborate with relevant manager for maintaining and developing the quality systems strategy, policies, processes, standards and procedures to ensure the site complies with regulatory and GMP compliance requirements as described by authorities and by Novartis/Adacap guidelines and quality manual.
Major Accountabilities
* Collaborate to ensure the site’s quality system is maintained compliant with regulatory and GMP compliance requirements.
* Collaborate in the management of the site’s quality systems documentation and reviews, define updates and approve (when agreed with the quality management) site-specific quality systems documents.
* Provide oversight for the implementation of quality systems and regulatory compliance, including management of non-conformances, CAPAs, effectiveness checks, change controls, training, inspections and audit readiness, technical complaints, risk assessments and remediation, annual product quality review, self-assessments, KPIs and quality management.
* Support the manager in the design and oversight of the strategic site quality system, and work in collaboration with site functions to define written procedures including monitoring and control of the manufacturing environment, training, document control/record retention, deviations/CAPA investigations, and monitoring compliance with all requirements of good manufacturing practice.
* Support the quality management to develop and deliver a robust overall quality system, strategy and ultimate plan resulting in a fully compliant quality system infrastructure with respect to procedures and processes.
* Provide oversight for audit and inspection management, inspection strategies, preparation, interactions and responses.
* Support the quality team in health authority inspection preparation and provide key support during MOH and Novartis global audits.
* Develop health authority communications, including written correspondence, responses to inspection observations, presentations and verbal communication.
* Work with the quality and compliance team to ensure robust quality systems are implemented and sustained, including deviation/CAPA management; ensure all deviations from established procedures are documented and investigated to determine and fix root cause.
* Support escalation of quality/cGMP issues and deficiencies to the Site QA Head and support global escalation process if needed. Support associates within the Novartis network in case of health authority notifications (e.g., FAR, Rapid alert, recalls).
Minimum Requirements
* Education: Bachelor’s Degree in Pharmacy or MSc in Pharmaceutical Industry.
* 2+ years of experience in a GxP (Bio)pharmaceutical or API manufacturing operations, up of which 1+ years of experience in a Quality Assurance role.
* Excellent communication skills.
* Fluent English and Spanish, written and spoken.
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture.
Benefits and Rewards
Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Seniority level
Entry level
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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