What are the responsibilities and job description for the Consultant with CSV Standalone Equipment Experience position at Implify, Inc.?
Company Description
Implify, Inc is a Global IT Solutions and Lifesciences services firm located in Newark, DE. Our projects range from trouble-shooting assignments to complete SDLC enterprise level engagements. Our services include Consulting Services, E2E Application Development, Re-engineering & Integration Services, and Professional Services. Our team comprises of full-timers with high standards of accountability, integrity & proficiency, and we focus on long-term relationships with our resources through transparency, performance-based recognition & advancement. Our deep domain knowledge in various sectors blended with software design, development & user experience has helped us to be ahead of the curve.
Role Description
This is a full-time on-site role for a Quality Assurance Lead. The Quality Assurance Lead will be responsible for managing and leading the Quality Control and Quality Assurance processes, implementing Good Manufacturing Practice (GMP) guidelines, performing Quality Auditing, and ensuring Quality Management.
Qualifications
- Experience in Quality Control, Quality Assurance, Quality Management, and Good Manufacturing Practice (GMP).
- Strong CSV (Computer System Validation) experience
- MES/PLC experience
- LIMS Validation experience
- Excellent written and verbal communication skills
- Ability to work collaboratively with cross-functional teams
- Experience in the life sciences industry is a plus
- Certification in related areas is a plus
- 8-10 years of experience performing validation activities
- Experience in performing Quality Assurance functions related to GMP and GVP (pharmacovigilance)
- Proficiency with FDA/MHRA regulations
- Use of computerized quality management systems
- Experience with validation of Enterprise/Lab Computerized Systems
- Knowledge of GAMP and Agile validation lifecycle and methodologies
- Experience in quality metrics, dashboards, analysis, and improvement programs
Location: Boston, MA (Hybrid – 3 days per week on site)
Contract Duration: 12 months, starting ASAP (possibility of extension)
Typical Responsibilities of a Quality Lead GMP:
- Onsite presence 3-4 days a week
- Understanding of regulations related to computerized systems in GxP areas
- Participation in system implementation project teams, providing guidance on System Lifecycle activities and validation strategy
- Review and approval of system life cycle deliverables for new and modified computerized systems in GxP areas
- Consultation with QA team members and internal stakeholders to identify high-risk areas focusing on patient safety, product quality, and data integrity
- Identification and escalation of areas of risk or non-compliance to manager/leadership team
- Participation in Periodic Review activities of Computerized Systems
- Support for regulatory inspection preparedness activities as needed
Requirements:
- Bachelor's degree in Biomedical, or biological sciences, or related field/experience
- 2-10 years of relevant industry experience in a cGMP environment
- Working knowledge of cGMP manufacturing and regulatory regulations for biotechnology, pharmaceuticals, and medical devices
- Experience in quality assurance tasks and remediation activities
- Experience in reviewing Master Batch Records and validation documents
Candidates should also have experience in creating and maintaining quality systems and be familiar with regulatory requirements for the industry.