Preparing for business abroad and national - How confident!
Approximately 30% Domestic and International travel
Through a quality system approach, ensure all GCP operations are in compliance, while maintaining an efficient workflow to facilitate operational excellence
Provide leadership and management within the department through a structural process of objective setting, performance appraisal and individual development as appropriate
Oversee and be ultimately responsible for quality assurance program; this includes overseeing and assisting with training and auditing programs, as well as the review of SOPs, investigations, validation reports, pharmacovigilance and AE reporting.
Prepare, review and approve external and internal reports and other documentation required by regulatory agencies, customers or to support the quality assurance function. Provide support and training to other staff members to develop additional auditing resources.
Act as company’s representative during regulatory agencies and customer inspections
Identify and lead operational excellence initiatives, both in the department and companywide, which result in the overall improvement in both areas
Partner with colleagues in other departments to increase the overall effectiveness of the Quality department
Audit the facilities of vendors, customers and outside contract organizations
They are clearly gearing up for production and distribution sooner than later. They are also sending signals to the market. I'm surprised that we haven't seen more increases in target share price from the analysts. Maybe after the Holidays they will get back to work.