The QA Operations Team Manager is responsible for providing first line QA Support and oversight of the MeiraGTx Quality Management System ensuring it is inspection ready and maintained in a state of control in compliant with applicable EU, UK and US GMP regulatory requirements.
Requirements
- Experience in leadership and team development
- Strategic thinking and risk management
- Experience of working within a sterile/Aseptic GMP manufacturing environment
- Understanding controlled processes
- Proficient in Microsoft office and experience in database and eQMS systems
- Excellent interpersonal skills
- Able to prioritize workload, decisive thinker able to work within agreed timescales
- A high level of attention to details
- Knowledge of GMP with regard's to QMS Activities
- Good team player and must be able to work alone
- Experience in competent authority, regulatory body inspections and audits
- Ability to work in a fast-paced environment