QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
- System Audit Trail Review (SATR) and approval for the manufacturing/QC Laboratory area.
- Manage the validation of in-house projects for computer and automated systems for Laboratory, Sterile, Non-Sterile and Utilities/Facilities Operations
- Manage, execute Data Integrity Assessments for computerized systems
- Manage and execute the Computerized Systems Periodic Review Program, including the periodic review of Data Integrity requirements for computerized systems.
- EBRs, Laboratory Analytical instruments upgrade initiative, and CSV IT Compliance activities including development of validation documents, routing, execution and all related CSV Lifecycle documents.
Qualifications:
- Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field.
- Previous experience in computer system validation within the pharmaceutical or biotechnology industry.
- In-depth knowledge of GxP and FDA regulations.
- Strong technical documentation and project management skills.
- Excellent communication and teamwork abilities.
- Problem-solving skills and informed decision-making capability.
- 5-8 years of experience in CSV
- Experience in pharmaceuticals, medical devices or biopharma
Top Skills
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools.
Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
