Senior Product Expert
Norgine Uxbridge, England, United Kingdom
We have an exciting opportunity for a Senior Product Expert to join Norgine.
Responsibilities
* 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 assigned product portfolio.
* Act as a Technical lead for products within portfolio and subject matter expert for products and processes within area of expertise. Provide product and process consultancy to manufacturing sites for improvement or investigations related to product deviations.
* Project Management and formal reporting of approved projects within assigned product portfolio for introduction of new products, new processes, line extensions, technical transfers and continuous improvement initiatives. Identify and prioritise tasks on critical path, influence and support project through cross‑functional collaboration. Manage project risks and budget with escalation where required.
* 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.
* Responsible for Global Technical support of Change Controls with potential impact on product quality within assigned portfolio.
* Pre‑assessment of proposed changes prior to a change control being raised. Mentor change leads on technical viability of proposed changes and key activities required.
* Lead change controls for process/product changes.
* Completion of Global Technical functional impact assessments.
* 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.
Qualifications
* Scientific Degree or equivalent; possibly a higher qualification in a discipline related to pharmaceutical sciences.
* Extensive knowledge of the pharmaceutical industry and experience of manufacture and supply of drug product. Experience of multiple dose forms, 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. 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.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Sales and Business Development
Industries
Non‑profit Organizations and Primary and Secondary Education
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