C&Q Specialist

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields. Log on now to our website http://www. qrcgroup.com / to learn more about our services and solutions! 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. 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) Benefits What We Offer Opportunities for learning, development, and professional growth.

A collaborative and supportive work environment. The opportunity to work with industry-leading clients on impactful projects. Your information will be kept confidential according to EEO guidelines.