QA Compliance Specialist, Auditing Novartis -
Holly Springs, NC
Job Purpose: Provides strategic support to relevant Quality processes regarding Audit Management of the site and the Supplier Management Program, including development and maintenance of quality procedures, and systems related to Audit Management. Provides technical support for the US FCC site in all cGMP compliance related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and the Novartis V&D Quality Manual requirements.
Major Duties:
Coordinate and facilitate assessments and follow-up activities of third parties such as suppliers of raw materials, drug products, container-closure systems, and packaging/labeling materials; external contract laboratories; GMP service providers; and contract manufacturing organizations.
Write follow-up letters and other communications to suppliers.
Issue, track and report follow-up status for supplier questionnaires, supplier quality audit responses and related CAPAs, and Quality Agreements.
Work with external auditors to compile relevant supplier data packages and provide summaries for supplier approval.
Attend internal supplier/material related meetings governing selection of new materials for the site and track/provide updates regarding the status of supplier/material approval.
Assist with maintenance of the supplier audit schedule, supplier status tracking and approved supplier spreadsheets.
Support supplier change notification review and approval.
Prepare and/or revise and assist with implementation of relevant SOPs.
Prepare supplier related presentations for Material Review Board and Quality Council.
Maintain supplier approval documentation and ensure the electronic audit information Management is kept up to date.
Conduct and author supplier related deviations and associated CAPAs.
Coordinate, conduct, and facilitate self inspections and follow-up activities of the Holly Springs Novartis operational areas.
Assist with maintaining the self-inspection audit schedule and related self inspection CAPA tracking.
Acquires and maintains knowledge of current local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters are provided to the site.
Participates on multi-functional continuous improvement (lean, six sigma, issue resolution, etc.) teams. Minimum requirements Requirements:
Bachelor’s degree in the field of Science or Engineering or other appropriate field of study
• Minimum of 3 years in Quality Assurance and/or in a GMP regulated environment within the pharmaceutical industry, including supplier management experience.
Sterile product manufacturing knowledge preferred. Biopharmaceutical experience a plus.
Strong knowledge of EU, FDA and cGMP regulations.
Supplier or contractor auditing experience preferred.
Experience in conducting investigations is required.
Excellent interpersonal effectiveness and written and verbal communication skills.
