QA Validation Associate
Rocky Mount Metro Area, NC
Applies the specifications of the organizational Quality Systems and Quality standards to ensure that the quality of processes and deliverables of project(s) meet their specified regulatory requirements.
Ensure that the site Quality Systems and Compliance activities are aligned with the Novartis Quality Manual and all relevant regulatory and legislative requirements.
Essential in providing Site E-Compliance guidance to all functional areas within the site by assuring the existence and maintenance of appropriate E-Compliance is in order to maintain a state of regulatory compliance.
Adhere to the quality system to meet and sustain compliance with internal and external regulatory requirements.
Conduct Quality Reviews of validation processes and deliverables to evaluate if they fulfil the requirements for quality, to uncover errors or deficiencies in processes and deliverables.
Review and approve site process validation, packaging validation, cleaning validation and revalidation strategies to meet cGMP requirements on time and quality to ensure that programs are compliant with inspection agencies requirements and related SOPs. To liaise effectively within internal and external functions and provides expert guidance on validation topics.
Ensures implementation of validation and transfer requirements by providing direction and support for quality / cGMP matters.
Ensures that the site has a comprehensive Validation Master Plan and that it is properly maintained and followed.
Follow up of identified validation deviations and escalation to QA management.
Interface with Quality Assurance and IT partners to ensure Novartis validation practices are aligned with regulatory expectations and best practices.
Prepae, or review and approve major system documentation to ensure consistency with quality standards and quality of deliverables. Coordinate documentation, testing, and change management activities to ensure compliance with business and regulatory needs
Computer Systems - Interprets complex technical quality requirements in specific situations, such as validation of new systems, upgrades, changes or remediation, to set validation/compliance strategy.
Reviews results of audits and periodic reviews and determines appropriate corrective actions. Oversees the application of corrective actions and may lead the work of lower-level resources and/or contractors, providing leadership and technical training.
Responsible for performing technical quality review and approval for GxP computer and Part 11 related documentation and interfaces with internal partners to analyze data and situations leading to sound decision-making.
Participates in developing the audit plans, executing the audits, writing the reports, communicating the results of the audits and conducting the follow-ups. Interacts with customers and suppliers on quality and compliance matters. May lead cross-functional teams.
Performs other duties as assigned.
Requires 5+ years of professional related experience. Detailed knowledge of cGMPs. Detailed knowledge and experience of computer systems validation. Part 11 experience and knowledge.
Experience with Trackwise, SAP, LIMS/Labware.
Proven ability to work in a team environment through conflict resolution and negotiations. Excellent written and verbal communication skills.
BS/BA in Chemistry, Engineering or applicable life sciences.