Description
A major pharmaceutical company is seeking x2 Senior Compliance Engineer to join their organisation on a freelance contract basis.The purpose of these positions is to ensure engineering activities are performed in a manner that is compliant with GMP`s, SOPs and Corporate policies and practices.
The Senior GMP Compliance Engineers are responsible to execute a Gap Analysis program across their biotech manufacturing campuses around the world.
You will be responsible for:
- Execution of gap analysis assessments across production portfolio
- Develop remediation plan for each site and globally
- Support Engineering comply to local procedures
- Monitor Audit Readiness of Site Services Engineering
- Ensures that all investigations, commitments & change controls are performed according to local SOP`s and corporate requirements.
- Works closely with Engineering System Matter Experts to ensure they are aware of all events entered into relevant IT systems
Experience/Educational Requirements:
- Degree; Engineering Qualification, (Process, Mechanical, Chemical etc)
- Extensive knowledge of GMP procedures and the EU and FDA guidelines
- Engineering experience of bulk bio (upstream or downstream and/or secondary(fill/finish)
- Working in international locations with multicultural teams
There will be extensive travel involved in this program so only individuals who are able to please apply. Contract will be until the end of 2012 with possible extensions; offering competitive rates of pay; please apply now for more information.