The Senior Validation Specialist is responsible for developing, executing, and managing Validation projects, including protocols, procedures, and training, within Piramal Pharma Solutions - Lexington. The primary purpose of the position is to provide technical and cGMP compliance support and expertise to activities performed under the validation lifecycle of the facility and its related systems, equipment, and processes. The position may specialize as a Subject Matter Expert representative in one (1) or more areas.
•Write, schedule, plan, manage, and execute validation and qualification protocols of manufacturing, packaging, laboratory, utility systems, computer software, product-specific process, and other equipment in accordance with global current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEP), and change control.
•Interact and collaborate with PPS client representatives and regulatory agencies.
•Peer review executed qualification protocols and drafted documents by other Validation staff. May be delegated as an approver based upon training and experience level, as determined by Validation management.
•Interact and coordinate technical activities with equipment and system suppliers.
•Coordinate and interface with operational, development, and quality departments to assure successful project execution.
•Represent the Validation department at project team meetings and provide expert validation advice.
•Perform routine duties as required in order to ensure the timely generation of accurate data and information.
•Maintain and develop technically-current knowledge applicable to existing and future validation processes and maintain up-to-date knowledge on regulatory expectations.
•Lead investigations related to validation event reports (discrepancies, deviations, etc.) and assure thoroughness of investigation, documentation and closure. Develop preventive/corrective actions as necessary.
•Conduct periodic validation reviews of equipment, facilities, utilities, and sterilization cycles.
•Author assigned Standard Operating Procedures (SOPs) for Validation department and/or other departments, as appropriate.
•Assist in training program development related to validation activities and concepts for both Validation personnel and other site departments.