Validation Specialist with a strong knowledge of injection molding processes to support the development, execution, and documentation of validation activities (Protocols, Tests, Reports). Familiarized with IQ, OQ and PQ validation phases for molds and equipment. IQ: Confirmation of Drawings (including mold attributes), Equipment, and Procedures (mold setup and operating), mechanical assessment of mold and equipment. Develop inspection programs and instructions for setup/positioning of tooling and parts. Assuring that all product development processes and relevant applicable documentation are executed according to the agreed Product Specific Design and Development Plans. Updating and defining Standard Operating Procedures (SOPs). Familiarized with Gage R&R methodology preferable. Preferably, familiarized with metrology equipment and methods such as calipers, micrometers, CMM, Programmable Vision Inspections Systems. Requirements Bachelor in Science Experience in FDA regulated industry 5 years of experience performing validation lifecycle activities Techical writting skills Read, write, speak and understand English and Spanish
QRC group is a life science firm dedicated to provide services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
Our services and solutions include:
Process and Laboratory Investigation
• Corrective and Preventive Action (CAPA)
• Change Control
• Training
• Document Management Control
• QA Laboratory
• Methodology Transfer and Validation
• Instrument Calibration
• Validation and Training in Chromatographic Data Acquisition System
• Cleaning Validation
• Automation Engineering
• Quality Systems
