Validation Specialist IV-WYETH-USA- Sanford, NC
Independently reviews and approves validation documentation including specifications, protocols and reports with a focus on cGMP impact and validation lifecycle requirements. Independently leads the QA input to validation projects in support of commercial manufacturing. Provides direction to project teams on compliance/technical issues related to validation efforts to achieve compliance with company policies and government regulations. Mentors junior level staff, providing coaching and guidance on company policies and regulatory requirements.
Job Responsibilities
*Independently reviews validation, calibration and corrective maintenance documentation for compliance with company policies and government regulations.
*Document approval including specifications, protocols and reports with a focus on cGMP impact and validation lifecycle requirements.
*Participates on validation project teams and provides guidance and direction from a regulatory compliance perspective. Actively and independently steer project teams to meet company policies and government regulations.
