- To project manage the technology transfer of API and secondary manufacturing processes from their current manufacturer to alternative sites
- To manage oversight of the Pharmanovia partner Contract Manufacturing Organisations (CMO) and ensure the Quality and Technical Agreements between Pharmanovia and its CMO organisations are prepared, agreed and followed.
- To Provide Technical advice and support on Manufacturing issues related to existing products and potential products.
Progress – Deliverables are being completed within the baselined time scales.
Cost – Deliverables are being completed within the baselined cost plan.
Quality – Deliverables are being completed to defined expectations, first time.
Reporting – Regular and timely reporting of project progress to the sponsors
Risk – To proactively manage foreseen project risk, mitigating as necessary.
Change – Managing changes to the project without unduly affecting the stated objectives and benefits.
Performance (Value) – Progress is being earned for the expected cost.
Regulatory – All required statutory and regulatory conditions are being met.
Key tasks and responsibilities
- Develop Project Plans, in conjunction with other relevant parties, in relation to product site transfers or new product development projects, to include timescales, costs and identifiable risks.
- Manage and implement agreed project plans in accordance with the product licences and GMP Guidelines.
- Ensure that issues are identified within the project are resolved, timelines are met and where necessary, appropriate data generated.
- Report issues / deviations from plan, costs, strategies timings and progress
- Generate, negotiate and see through to approval the Quality and Technical Agreements between Pharmanovia and its partner Contract Manufacturing Organisation
- Generation, review and technically approval of Technical documentation including but not restricted to Protocols, Manufacturing and Packaging Batch Manufacturing Records, Validation Reports
- Ensure compliance in Technology Transfer and Process Changes with EU GMP under the supervision of a nominated Qualified Person (QP)
- Resolve Technical and Quality issues including unforeseen deviations relating to the production and testing of products by Contract Manufacturers and Testing Laboratories. Report issues to the QP who is responsible for releasing these products to the market.
- Maintain up to date knowledge of Regulatory and Quality Management requirements, as needed to support the contract manufacture of current products and the introduction of new products.
- Work with Regulatory, as part of a multidisciplinary team, regarding new and existing licence applications or variations
- Assist in sourcing alternative API suppliers and secondary manufacturers.
- Assist when required, in technical Due Diligence and support in relation to the acquisition of new products, licences and / or dossiers.