Newark Metro Area, NJ
Responsible for oversight of qualified and validated equipment and systems in compliance with policies, guidelines and procedures.
- Develops protocols, and associated reports while adhering to a change management process.
- Supports the execution of equipment qualifications and validation protocols
- Supervises vendors for qualification functions.
- Develops written procedures for calibration and preventive maintenance of equipment
- Supports calibration, equipment qualification and validation activities.
- Configures and documents the configuration of computerized systems
- Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls..
- Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
- Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.
- Completes all calibration, qualification and validation documentation with accuracy, completeness and compliance to standards.Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry
- Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance
- Ability to work with the end user to identify and document User and Functional Requirements
- Knowledge of pharmaceutical laboratory and manufacturing systems.