Description
Our client, a multinational company in the pharmaceutical industry currently requires a Project Manager with Lifescience experience
Start: 1/9/13
Length: to be confirmed
Location: South of Brussels
FUNCTION DESCRIPTION:
The Project Coordinator/Manager will be focused upon supporting major RA regulatory compliance programs ongoing.
She/he will support the Regulatory, Quality/Manufacturing and Supply organisations to manage delivery, quality and timelines.
KEY RESPONSIBILITIES:
* Develop, update and communicate robust and predictable project plans utilising project management best practice
* Drive execution, coordinate and track progress of project schedule;
* Interface with appropriate functional groups to source required documents;
* Coordinate Vaccine CMC Edge operational meeting (eg, meeting invites,agenda, preparation and distribution of meeting minutes)
* May represent Regulatory Affairs in teams under supervisor directions
* May be required to write documents, including for example, SOPs,Guidance documents etc.
* Responsible for the follow-up of specific assigned QualityImprovement Programs (QIP), including coordination between the RAmanagers involved in QIP programs
* Under supervisor direction, manage documentation/provide RA impactevaluation in relation with change control process and in accordancewith post-approval guidances
* Provide consolidated RA feedback to QIP Project Teams, as appropriate
* Ensure QIP program progresses and RA impacts are identified and communicated to RA Organization in a timely fashion
* May represent Regulatory Affairs in cross-functionnal project teamsunder supervisor direction
PREREQUISITES:
Education
* A university level degree in a scientific discipline (life Sciencesis preferred) with appropriate Project Management methodology qualification &/or good Project Management experience
Knowledge
* A knowledge of the pharmaceutical industry (the ideal candidate would have a broad overview of Manufacturing, Quality, Supply and Regulatory);
* A more detailed knowledge of RA aspects in general would be helpful;
* An understanding of the principles of GCP, GMP, and ICH guidelines;
* Knowledge in the use of document management tools and techniques;
* Knowledge of biological products and process equipment.
* Experience in change control process (RA impact evaluation)
Skills
* Attention to detail, ability to product documents of high standard.Must demonstrate integrity and consistent work approach;
* Strong organizational and interpersonal skills
* Ability to work in a team environment with shifting priorities and requirements
* Excellent English skills - both written and verbal
French is an asset.
* Good communication skills
* Writing skills
* Analytical skills, creative and critical mind
* Team player
Tags: Project Manager, Gestion de projet, Life science,Pharmaceutique, Pharmaceutical, GMP, GCP, Regulatory, Règlementaires