Job Description

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 Senior Product Expert to join Norgine.


The Senior Product Expert is responsible for the execution of Product Lifecycle Management activities inline with ICHQ8-10/12 for their assigned product portfolio across Norgine sites and Contract Manufacturing Organisations (CMOs). They are responsible for providing in-depth technical expertise to support pharmaceutical manufacturing across a product portfolio which may contain a range of doseforms and 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. It is anticipated that the Senior Product Expert will be a subject matter expert for at least one dose form and be able to provide technical consultancy to the wider team when required.


If you want a multi-dimensional 3D career in a leading healthcare organisation, join us.

Requirements

KEY RESPONSIBILITIES & ACCOUNTABILITIES:


1. Responsible for the execution of the Product Lifecycle Management (PLM) activities for assigned product portfolio of commercial products from raw materials to primary pack:

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

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 the 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 Global Technical support of Change Controls with a potential impact on product quality within their assigned portfolio.

Pre-assessment of proposed changes prior to a change control being raised. Mentoring of change leads on the technical viability of a proposed changes and key activities required. Leading change controls for process/product changes. Completion of Global Technical 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, co-ordinate and execute CAPA's.


RELATIONSHIPS:


1. Report directly to the Associate Technical Director or Senior Technical Manager


2. Work cross functionally as a project lead or team member on approved projects with representatives from global and local departments (such as Quality Assurance, Production, Supply, Regulatory, Finance and Commercial) plus CMOs and partners where applicable.


3. Acts as a point of contact for the business for Technical information relating to their assigned product portfolio


4. Formal reporting of project status to Global Technical Management, Project Sponsors, Site and EN Directors, CMOs and Partners.


SKILLS & KNOWLEDGE

Scientific Degree or equivalent possibly a higher qualification in a discipline related to pharmaceutical sciences. Extensive knowledge of the pharmaceutical industry + experience of the manufacture and supply of drug product. Experience of multiple doseforms, product development or drug substance manufacturing would be advantageous. Proven ability in managing 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 of managing 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

Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.


Sound good? Find out more about the career you'll have with Norgine, then apply here.



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