Senior Product Expert 12-month FTC
Norgine
- Centre-Val de Loire
- Contrat
- Temps-plein
- Responsible for ensuring information of sufficient scientific depth is available for the product risk assessment and the generation of the associated risk management documentation.
- Working with the engineering, packaging and analytical functions (internally or externally) to ensure risks to product quality from the manufacturing or primary packaging equipment/process, container closure system or analytical methods are adequately identified and managed as part of the product risk assessment.
- Responsible for documentation of generated product and process knowledge via development reports and subsequent generation/update of Product Lifecycle Management documentation.
- Responsible for Process Validation and Ongoing Process Verification of their assigned product portfolio
- Pre-assessment of proposed changes before a change control being raised. Mentoring change leads to the technical viability of proposed changes and key activities required.
- Leading change controls for process/product changes.
- Completion of MS&T functional impact assessments.
- Scientific Degree or equivalent possibly a higher qualification in a discipline related to pharmaceutical sciences.
- Extensive knowledge of the pharmaceutical industry with at least 5 years of experience in the manufacture and supply of drug products. Experience in multiple-dose forms, product development or drug substance manufacturing would be advantageous.
- Proven ability to manage complex Technical activities in a pharmaceutical environment
- Proven Project Management of product change projects, continuous improvement initiatives and technical transfers in a multinational environment.
- Knowledge of the Regulatory compliance requirements within Europe, Japan and the USA.
- Demonstrated experience in the management of root cause analysis investigations.
- Ability to manage, multiple, cross-functional projects to deliver against key project milestones and deadlines.
- Experience in managing the workload of small teams to meet deadlines
- Excellent verbal and written communication skills, in English (Other languages desirable e.g. French or German) with the ability to present effectively to groups.
- Excellent influencing skills and ability to establish effective working relationships with personnel at all levels.
- Thorough working knowledge of ICH guidelines and current Good Manufacturing Practices.