Description
This mid sized Pharmaceutical company is looking for a well rounded Validation professional who has a background in either analytical method validation or process validation. Equipment, facilities, and computer validation are a plus as well. This highly sought after company is expanding rapidly and looking to book interviews asap.- CMO project management
- Collaborates with management and technical 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.
- 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.
- Reviews change controls for new and upgraded processes, analytical methods, computer systems, equipment, and facilities to meet internal company and external government requirements.
Please respond with contact information if interested: b.ross(@)realstaffing.com
To find out more about Real please visit www.realstaffing.com