Mandatory Skills: Pharma IT, GxP Project, PMP Certification
Domain Experience
• Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
• Broad knowledge of drug development process and client needs
• Prior experience working on regulatory submissions
• Familiar with 21 CFR part 11, GXP and other Life Sciences regulations
Technical Experience
• Experience with LIQUENT Insight publisher, Veeva platform strongly preferred; however, consideration will be giving to candidates with experience with other electronic publishing systems
• Experience with Waterfall and Agile development
• Thorough understanding of Software Development Life Cycle (SDLC) and all related documentation
All your information will be kept confidential according to EEO guidelines.
Skills Required
- PMP Certification
- Working knowledge of ICH Guidelines and GCP
- Experience with regulatory submissions
- Experience with LIQUENT Insight or Veeva
- Familiarity with 21 CFR part 11 and GXP
- Understanding of SDLC and documentation
What We Do
Established for more than two decades, KRG Technologies, Inc., headquartered in Valencia, CA, is a distinguished leader in Workforce Solutions, Microsoft Technology Solutions & Services, and Edge Computing (iOT) across the USA, Canada, Dubai, and India. Recognized as a Great Place to Work for two consecutive years, and a five-time honoree by Inc5000, and certified with ISO 9001 and 27001, KRG Technologies has demonstrated a steadfast commitment to excellence and innovation in the Information Technology & Services industry. KRG specializes in providing all-around workforce solutions, developing advanced digital applications, Microsoft solutions, and Edge Computing(iOT) for smart spaces. Well-known for getting things done, we focus on finishing work on time and sticking to the budget without sacrificing quality. We are good at making cost-effective solutions that not only meet but go beyond what the client wants, making sure everything goes smoothly and gets the best results. The purpose of KRG’s existence is ‘employment creation’ and we want to have long-term relationships with our employees and clients. To do this, we follow the important principles of being honest and transparent. We offer customers the advantages of: • Software development processes - flawless execution and project management. • Leveraging a combination of proven onsite and offshore • Professional Services Unit to augment your onsite team capacity/capability • Commitment to meet your objectives "on time - within budget" • Aggressive Pricing & Proven Track Record.
