Société : Norgine Lieu : Dreux Centre-Val de Loire
ABOUT THE JOB Want a 3D Career? Join Norgine.
At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.
We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.
Bring everything about yourself that you're proud of, whether that's your passion for making a difference, focus on others' well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.
In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people's wellness as much as you do.
Because at Norgine, we transform lives with innovative healthcare solutions.
We have an exciting opportunity for a SeniorProductExpert to join Norgine on a 12-month Fixed Term Contract.
The person holding this position will report to the Senior Technical Manager and be a member of the Operations team.
The core responsibility is to provide in-depth technical expertise to support pharmaceutical manufacturing across a product portfolio which may contain a range of dose forms therefore strong transferable skills are required.
To ensure that products within their portfolio are well understood and risks to product quality are identified, prioritised and mitigated where appropriate.
If you want a multi-dimensional 3D career in a leading healthcare organisation, join us.
Please note this 12-month contract can be based either in Dreux or Rueil Norgine site.
Requirements KEY RESPONSIBILITIES & ACCOUNTABILITIES 1.Responsible for the execution of the Product Lifecycle Management (PLM) activities for the assigned product portfolio of commercial products from raw materials to primary pack:
â?¢ Responsible for ensuring information of sufficient scientific depth is available for the product risk assessment and the generation of the associated risk management documentation.
â?¢ 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.
â?¢ Responsible for documentation of generated product and process knowledge via development reports and subsequent generation/update of Product Lifecycle Management documentation.
â?¢ Responsible for Process Validation and Ongoing Process Verification of their assigned product portfolio 2.
Act as a Technical lead for products within their portfolio and subject matter expert for products and processes within their area of expertise.
Provide product and process consultancy to manufacturing sites where improvement to product performance is required or to support investigations related to product deviations.
3.Project Management and formal reporting of approved projects within their assigned product portfolio for the introduction of new products, new processes, line extensions, technical transfers and continuous improvement initiatives.
Identifying and prioritising tasks on the critical path, influencing and supporting the project through cross-functional collaboration.
Management of project risks and budget with escalation where required.
4.
Author CMC sections of regulatory dossiers/supporting information for post-approval changes and support regulatory compliance initiatives including gap analysis, responding to RFIs, regulatory incidents and post-approval commitments.
5.Responsible for the MS&T support of change controls with a potential impact on product quality within their assigned portfolio â?¢ 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.
â?¢ Leading change controls for process/product changes.
â?¢ Completion of MS&T functional impact assessments.
6.Lead and/or provide technical support utilising lean six sigma techniques for investigations linked to Quality Events, Customer Complaints and IMC actions.
Provide technical recommendations, coordinate and execute CAPA's.
SKILLS & KNOWLEDGE 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.
Benefits Benefits vary between locations.
Sound good? Find out more about the career you'll have with Norgine, then apply here.
Norgine DreuxCentre-Val de Loire Expérience souhaitée
