Main purpose of job:
- QP release of Third Party products
- Responsible for ensuring that the required checks/systems are in place with contract CMO/CRO and MAH to support release.
- Provide QP Declarations, review approve, analytical, microbial and operational investigations from Third Party Manufacturers and assess the impact to batch certification.
- Support the generation of quotations for new business, established product updates and new SKU extensions in line with the standard EU ways of working.
- Management of all NPI Quality & Regulatory associated tasks to site ensuring integration into all site wide business units
- Support the annual review of all SKU’s to ensure process is still fit for purpose and meets the agreed costing and margin in line with the standard EU ways of working.
- Provide a Quality and Regulatory Function to the NPI Business Unit (BU) infrastructure to support the site operational, commercial and business development functions.
- Development, maintenance and standardisation of the EU NPI Quality ways of working including but not limited to databases, specifications, templates, SOP’s and training while ensuring compliance with non- NPI project / routine business ways of working.
- Preparation of regulatory submissions as deemed necessary via the NPI on-boarding process to appropriate health authority.
- Review and approval of NPI Project documentation to include Validation protocols & reports, Change controls, SOPs (new and modified) and Batch Packaging Records (BPRs).
- Preparation of the monthly and/or quarterly Quality report the site Quality Management team.
- Monitoring, controlling and reporting of the Quality elements of the NPI CER budget and or on-boarding costs incurred including but not limited to travel and expenses.
- In conjunction with the operational group assist in technical, product and process reviews to resolve operational, performance and functional issues.
- Build, develop and sustain the knowledge, capability and competency with the NPI team to support ongoing and changing technologies employed to meet the business objectives.
- The job holder may have indirect people management responsibilities for their NPI sub project team members and ensuring that all KPIs, targets and any other deadlines are met individually and by the team.
- Sterile experience with biotechnology QP release experience.
- Previous QP releasing experience, specifically third-party release. You should have experience with NPI and onboarding of new products while working in a cGMP environment.
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