QA Expert

This position will be located at Morris Plains, NJ and will not have the ability to be located remotely.

The QA Operations Expert is responsible for first level, hands on, cGMP facilitator role for all site related GMP activities. They interact directly with site staff, who are performing the daily operational functions in support of their effort to produce quality products. This role ensures that the quality strategy is implemented and that there is a continuous drive to improve product and process quality for make, test, and release as well as all other support functions. They are also responsible to serve as quality project team representatives for continuous improvement initiatives on site, as applicable
#LI-Onsite

Key Responsibilities:
• Execute, lead, oversee, and provide direction for the following QA related daily operations, from a subject matter expertise perspective
o QA Shopfloor activities in the Manufacturing and QC environments providing best practice coaching activities in the production, QC labs and other support areas on site, in accordance to Novartis policies, SOPs, and cGMP requirements. Non-conformance/Quality Event/OOS investigation quality review in accordance with Novartis policies, SOPs, and cGMP requirements.
o Oversight & Governance of aseptic operations including but not limited to ViMOS, Aseptic Process Validation program, walkthrough program, EM monitoring program, etc.
o Deviation handling and Governance. Initiation, review and approval of initials & Impact assessment, deviation and OOS/OOE/OOT investigations and CAPA plan establishment in accordance with applicable SOPs.
o Final Product PP/FP release and disposition activities. Handling and addressing all Patient batch release communications with/from various stakeholders. Add
o QA data review of associated batch records, procedures and related documentation to ensure adherence to Novartis policies, SOPs, and cGMP requirements. Review and audit production-based batch records, procedures, and validation documentation to ensure adherence to Novartis policies, SOPs, and cGMP requirements.
• This role will consult and collaborate, successfully, with Engineering, Facilities, Quality Control, MS&T and Process Unit personnel as deemed necessary by the individual or QA management
o Quality review of validation life cycle documents, including user requirement specifications, plans, protocols and reports in adherence with SOPs, corporate policies, standards and government regulations. Through these reviews/support the individual will provide quality requirements guidance to validation document authors to ensure high-quality documents that demonstrate consistent approach, in compliance with requirements
• Provide support for all Internal, external and, Health authority audits by involvement and interaction with audit management team and/or inspectors. Provides Quality oversight to complex qualification activities and projects
• Provides timely review and approval of Equipment and Process validation plans, protocols, summary reports and deviations to ensure project timelines are not impacted. Coordinates and develops with PU, QC and MS&T qualification projects and plans and identifies the
• “critical to quality” parameters impacting qualification activitie
• Reviews and approves Site Validation Master Plans, Risk and Impact Assessments as appropriate
• Provides QA review and guidance on asset and Product change request in consultation with change request owners to evaluate validation impact.
• Advises and consults with other departments on equipment, analytical instrument and computer system validation.