The Validation Specialist II is responsible for ensuring compliance to the regulatory requirements of the facilities, utilities, equipment and analytical instruments qualification processes and activities performed in the Novartis, Morris Plains, NJ facility. Recommends and implements improvements of the qualification process. Performs a variety of routine and non-routine tasks related to facilities, utilities, equipment and analytical instruments qualification, as managing and overlooking qualification projects and changes. Prepares risk and impact assessments and other evaluations. Supports Process Unit (PU), Manufacturing, Science and Technology (MS&T), Operations (OPS), Quality Control (QC) and Quality Assurance (QA) departments.
Provides oversight to complex qualification activities and projects
Manages multifaceted qualification activities with limited oversight
Coordinates Qualification activities in compliance with corporate policy, local procedures and regulatory expectations
Coordinates and develops with PU, MS&T, OPS, QC and QA Teams qualification projects and plans and identifies the "critical to quality" parameters impacting qualification activities
Prepares Qualification Master Plans, Risk and Impact Assessments, Protocols and Summary Reports and coordinates review and approvals of the documents
Authors/reviews/updates/assists in developing departmental standard operating procedures (SOPs) and qualification programs
Conducts field execution of Installation, Operational and Performance Qualification protocols
Assists PU, MS&T, OPS, QC and QA colleagues, as necessary
Ensures that all activities are in compliance with cGMP, Health Authority regulations and the Novartis Policies
Determines of Qualification requirements based on a worst case matrix approach for the site
Provides qualification solutions that meet regulatory requirements within budget, where applicable.
Supports/assists 3rd party/ vendor qualification activities, if applicable.
Support qualification/validation projects as allocated.