Quality Assurance Consultant with GMP experience

Requirements:
- Degree in Chemistry/Pharmacy/Biomedical or related studies
- Relevant experience with lab instrumentation or pharmaceutical manufacturing
- Previous experience with Quality Management System documentation
- Knowledge of GMP, GAMP and FDA guidelines would be preferable
- Knowledge in IQ/OQ/PQ of instrumentation or computer systems is highly preferable
- Computer skills for MS Word and Internet
- A good team player with dedication and commitment to meet project timelines
- A good command of the English Language for international projects and report writing
- Strong oral and written communication skills

The position for a leading Quality Assurance and regulatory affairs consultant will be responsible for managing GMP validation documentation and conducting GMP regulatory compliance audits.
The position involves authoring and reviewing validation plans and protocols (IQ, OQ, PQ), summarizing validation activities and reports, performing internal and external audits, and adherence to SOPs and corporate policies.

The QA Consultant will be working as part of an international team on both product development projects and large scale on-site validation projects. Projects are located both in Romania and at international clients so some travelling will be expected.

IP Devel is the leader in Romanian complex IT offshore outsourcing services. The success of this dynamic company relies both on the service-oriented business strategy, unique to Romania, and team ability to engineer some of the newest, most innovative and challenging projects worldwide. IP Devel is the sole Romanian provider of a unique set of skills in the software offshore outsourcing world. IP Devel has been supplying its clients in Asia, North America and Europe with over 300 customized software solutions, and has achieved significant growth yearly.