The QMS Master Control Specialists will be managing the implementation and a junior level person will be
working to prepare for the system change.
The company is currently paper-based / Word / PDF and all documents need to be reformatted to Master
The first part of the project will be to clean up current documentation and revise the formatting.
The lead consultant must have experience with managing previous Master Control implementation projects.
1. The lead consultant will manage the day to day operations of the project and continually communicate
with the vendor (MasterControl) as it progresses, track progress, assess risk, ensure timeline of the
project is on track and keep in communication with upper management. This person should have Project
Management experience but must be a Master Control specialist more than a strict project Management.
2. Assist in the generation of the change control
3. Review Installation/Operation qualification (IOQ) validation packages of the system.
4. Perform or review the performance qualification (PQ) validation package of the system.
The junior level consultant must have QMS experience and Master Control will be welcomed.
1. The junior level consultant will be revising and organizing documents for the system change.
2. Review new system workflow to be adapted to existing procedural workflows.
3. Perform other project related tasks as assigned.
Both candidates must have previous life sciences experience. Biotechnology or Medical Device,
Knowledge and Experience:
1. Master Control, Electronic Document Management System (EDMS), QMS, Project Management skills
2. Bachelors Degree in the life sciences
3. Minimum 1 year experience in Project Management
4. Minimum 4-5 years industry experience – Quality Management
5. Minimum 3 years experience within document control will be an advantage
6. Proficiency with Microsoft Office Suite and Visio; ability to maintain database systems preferred
7. Able to prioritize work flow daily and execute on multiple priorities in a fast paced environment
8. Excellent verbal and written communication skills
9. Demonstrated proficiency in preparing and delivering presentations
Keywords: Pharmaceutical, Biotechnology, Quality, Drug, GMP