We are seeking a C&Q Specialist with expertise in execute qualification activities around an OEM-driven retrofit to an existing GMP manufacturing isolator. Responsibilities: Prepare and maintain all commissioning documentation. Coordinate execution with contractor and vendors. Maintain commissioning status reports. Coordinate closure of deficiencies. Participate in project meetings. Support turnover to Operations and Maintenance. Maintain commissioning records. Provide editable electronic copies of all deliverables. Provide final PDF copies of all approved deliverables. Requirements Bachelor Degree in Science or Engineering or related field. Background in pharmaceutical products manufacturing environmental specially in sterile packaging area. Experience in commissioning and qualification. Strong knowledge of cGMPs regulations. Startup and operational readiness experience. More than 5 years of experience in commissioning related projects. Experience in digital validation solutions. Good skills writing validation/commissioning, and technical documentation in English and using MS Office applications. Bilingual (English & 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
