Page 40 - MBE-Digital-Catalog-2024

REGIONAL AFFILIATE OF NMSDC

QRC GROUP, LLC

Sector : Pharmaceutical, Diagnostic,
Medical Device, Biotech Injection
Molding Industries
Web Address : www.qrcgroup.com

Tel : 939-336-7724 / 787-746-2600

Email : eaponte@qrcgroup.com

Contact : Eira Aponte, General Director

Company description: • Development and review of procedures,

including computing systems such as TrackWise
QRC Group specializes in validation and regulatory • Event investigation support
compliance consulting services since 2005. We deliver • Complaints investigations
top quality validation, regulatory and compliance solutions • Change control management
through the selection, training and support of our resources, • Training support
which serve the pharmaceutical, medical device and biotech QUALIFICATIONS/VALIDATIONS:
industries. • Computer System Validation (Life-Cycle and
Data Migration) and IT
For more than thirteen years, QRC Group has been providing • Equipment validation
project life-cycle activities, ranging from early project (manufacturing, packaging or laboratory)
planning/design through to the verification and qualification of • System Validation (Water systems, HVAC, etc.)
critical aspects of manufacturing systems /equipment and the • Utilities and facilities
final process validation stages. Our personnel are up-to-date • Product and Technology Transfer
information on current applicable regulatory and international
standards and guidelines, together with a current industry REGULATORY:
approach to commissioning, qualification and validation. • Vendor certification
• Regulatory agencies - policies trainings
We provide consultancy services for national and international • Quality System Records (QSR) generation for
clients within an interesting, growing market and with agencies response.
strategically relevant projects. This includes: COMMISSIONING AND DECOMMISSIONING:
• Professional consultants… • Commissioning Plans and Services
a highly motivated team! • Facilities Qualification
• GMP compliance mindset • Decommissioning plans and reports
• Ownership mentality from our Consultants for (equipment, systems, data or facilities)
shaping and defining new projects within our
service portfolio
• Promising opportunities for personal NEW (PRODUCT/SERVICES/SOLUTIONS)
development within a growing company FOR THIS YEAR:
• Temporary Staffing Services
Product/Services/Solutions:

QUALITY SYSTEMS:

40 PUERTO RICO MINORITY SUPPLIER DEVELOPMENT COUNCIL