Sr. Process Validation Specialist

* Collaborates with internal and external technical and management personnel to establish project priorities, goals, structure, and optimization of validation approaches.
* Develops, executes, and analyzes validation projects to demonstrate process consistency, facility, equipment and cGMP compliance to FDA and EMA regulations and ICH guidelines. Reviews and approves associated protocols and reports.
* Provides oversight and applies lifecycle concept for process validation activities of drug substance and drug product manufacturing.
* Reviews and approves internal and external analytical test method validation protocols and reports.
* Evaluates internal equipment and systems, identifies critical features, and defines appropriate test plans, protocols, data records, and deliverables.
* Applies risk-based analysis to assess and prioritize the requirements for validation.
* Reviews test requirements and scripts, identifies, resolves and approves test discrepancies to ensure accurate records and summaries of test results.
* Interfaces between various internal and external functional areas to assure successful integration and completion of validation activities in overall project schedules.
* Collaborate with cross functional teams to develop requirements (URS/FRS) for systems, applications and equipment.
* Applies quality standards, policies, procedures, and knowledge of current industry/regulatory standards for validation implementation, execution and completion.
* Administers and coordinates the metrology (calibration) program.
* Maintains awareness of regulatory and compendial requirements.
* Reviews change controls for new and upgraded processes, analytical methods, computer systems, equipment, and facilities to meet internal company and external government requirements.
* Performs other duties as assigned by managerTo find out more about Real Staffing please visit www.realstaffing.com