CY Partners have an exciting new opportunity to work with a leading global pharmaceutical company as a Compliance Specialist. The opportunity will be at their site in Hertfordshire. It would be an excellent role for someone with previous experience in compliance, as well as a QA specialist experienced in delivering Change Control systems.

Role Responsibility’s 

• Support delivery of Change Control systems and processes including assessing proposals for completeness/compliance with procedure and tracking approvals as part of the CGT Change Control Panel approval
• Follow up on overdue Change Control actions and deliverables
• Support CGT Change Control Process Owner in administration of Change Control Panel meetings
• Generation of reports and metrics (including trending) from systems including C3 QWF
• Management of change control queries from CGT platform regarding process and system
• Support the CGT platform in transition from QWF system to VQMS system
• Escalating for awareness, consideration and action concerns/ risks which may impact or disrupt delivery of medicines in the pipeline
• The position will involve forming positive and productive internal relationships

Key Requirements

• Sc. And or relevant industry experience
• Experience of Change Control in the Pharmaceutical Industry/GMP environment
• Strong skills in Microsoft Office applications (formatting Word documents and working in Excel)
• Must be strongly engaged in continuous improvement
• Knowledge in Good Manufacturing Practices
• Must be able to work in a team oriented, fast paced environment
• Must be able to quickly respond to changing priorities
• Ability to closely monitor and communicate progress on daily tasks and responsibilities to Management.
• Excellent organizational and time management skills
• Excellent attention to detail, with the ability to operate at both a detailed and summary level, and to put data analysis into context by seeing the bigger picture, to spot trends and extrapolate

Tagged as: cGMP, change control, Change controls, Chemical Compliance, Chemical Quality Compliance Advisor, compliance officer, document control, document management, EDMS, GMP, QA, Quality Assurance, Quality Compliance