Quality Assurance IT/CSV Specialist
- Contract Type
** 12 months contract**
** Competitive rates **
The successful person will provide IT compliance/validation support to the ERMD/AIT Team to ensure compliance with Computer Systems Validation (CSV) and Systems Development Lifecycle (SDLC), Cyber Security and Data Integrity.
- Prepare plans for remediation of legacy systems and implementation of new systems
- Deliver effective and efficient running of CSV Compliance operations in the ERMD/A&IT team.
- Provide Compliance support, guidance and expertise
- Providing ongoing IT compliance/CSV support.
- Become SME of SDLC/CSV policies and procedures.
- Ensure supply of all compliance components required to deliver high quality product through tactical planning and execution of project and compliance deliverables; including change-control, cyber security, data integrity, training etc.
- Ensure highest Quality & Compliance standards.
- Generation and execution of documents such as User Requirements Specifications, Design Specifications, FAT, SAT, IQ, OQ, PQ etc.
- Participate and Comply with the MMD Quality Management System (QMS) requirements and regulations, including:
- EU Annex 11
- 21 CFR Part 11
- MHRA (UK) GMP Data Integrity guidelines
- Sarbanes-Oxley (SOX ) regulations
About Planet Pharma
Planet Pharma was founded by a dedicated team of seasoned professionals with extensive experience supporting the pharmaceutical, biotechnology and device industries. Our goal was to create an organization that strengthens the employer-employee dynamic by connecting clients with talent — ultimately making staffing more personal and creating enduring, valuable relationships. We are able to achieve this by leveraging cutting-edge technology and flexible service delivery models that enable us to provide personalized solutions.
At Planet Pharma, the decision makers are at the table, with the tools and expertise to go beyond expectations. Our global Headquarters is located in Northbrook, IL and we have branch offices throughout the United States and Europe. All locations operate with shared attributes that are at the heart of everything we do:
Innovative – We constantly explore new ways of working that will help us be more efficient and effective Entrepreneurial – We look at things differently, immerse ourselves in your world and devise solutions for each and every client
Expert – Everyone on our team is an expert in their field, trained and continually learning to deliver an unrivaled level of experience
Passionate – We are all incredibly proud to be part of Planet Pharma and we genuinely care about the people we work with We provide the following solutions:
Contract Staffing, Outsourced Projects, Permanent Placement and Managed Service Provider Specialities: Clinical & Scientific Staffing, Technology Staffing, Site Management & Monitoring, Clinical Project & Program Management, Clinical Programming & Data Management, Biostatistical Analysis & Reporting, Pharmacovigilance, Medical Writing, Regulatory Affairs, Quality Assurance and Validation.
CHICAGO | SAN FRANCISCO | BALTIMORE | LONDON | RTP