Study Management Analyst
Central Employment is looking for a Study Management Analyst within the Stability team of one of our pharmaceutical clients. Stability is responsible for performing stability testing on pharmaceutical products from multiple manufacturing sites within the internal company network and also from external manufacturing sites. The CQCL (Cramlington Quality Control Laboratories) has a staff of approximately 90 employees and supports worldwide stability requirements. The CQCL mission is to be a flagship department that provides a World Class Service end-to-end stability service that meets regulatory and customer requirements. The Study Management team is office-based and ensures the stability studies are set up in compliance with internal and regulatory requirements. The Study Management Analyst role includes starting stability studies to meet regulatory requirements, retrieving samples from stability chambers and performing stability annual reviews. This role is for 12 months to cover maternity leave but there is potential for this to be extended.
- Study Initiation and management, including “send only” samples
- Sample storage, retrieval and management
- External Testing
- Stability Annual reviews
- Completed/ Cancelled Studies
- Requests (customer, site and data)
- Send only samples
Qualifications, Skills & Experience Required
- Have an acute understanding of GMP processes and requirements and have Quality experience
- Excellent communication skills
- Self-motivated and well-organised
- Forward-thinking and solution-focused
- Document review skills
- Computer literate (excel, word, LIMS)
- Ability to work as part of a team.
- Accuracy and attention to detail.
Guaranteed increase to £26,000 after 12 weeks of employment.